[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of vemurafenib tablets in healthy subjects under fasting and fed conditions

主要目的：评价健康受试者空腹/餐后单次口服维莫非尼片（240 mg/片）和佐博伏®（参比制剂）（240 mg/片）的药代动力学（PK）行为，评价两种制剂的生物等效性。次要目的：评价健康受试者空腹/餐后口服两种制剂的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) behavior of vemurafenib tablets (240 mg/tablet) and Zelboraf® (reference formulation) (240 mg/tablet) after single oral administration on an empty stomach or after a meal in healthy volunteers, and to assess the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the two formulations after oral administration on an empty stomach or after a meal in healthy volunteers.

Start Date28 Aug 2025

Sponsor / Collaborator

Shanghai Kechow Pharma, Inc.

ChiCTR2500105081

/ Not yet recruitingPhase 4IIT

A prospective, single-arm, open-label exploratory clinical study evaluating the efficacy and safety of the combination therapy of toramatinib, vemurafenib and cetuximab in the first-line treatment of unresectable or advanced BRAF V600E mutant colorectal cancer

Start Date01 Jul 2025

Sponsor / Collaborator

Ruijin Hospital

100 Clinical Results associated with Vemurafenib

100 Translational Medicine associated with Vemurafenib

100 Patents (Medical) associated with Vemurafenib

3,246

Literatures (Medical) associated with Vemurafenib

01 Jul 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Cutaneous Adverse Drug Reactions Associated With BRAF and MEK Inhibitors: A Real‐World Analysis of WHO Pharmacovigilance Data

Article

Author: Giedziun, Piotr ; Calik, Jacek ; Sauer, Natalia ; Wiela‐Hojeńska, Anna

BRAF inhibitors and MEK inhibitors (MEKi) have reshaped the treatment of BRAF V600 ‐mutant malignancies; however, cutaneous adverse drug reactions (ADRs) remain a frequent and clinically impactful toxicity. Although clinical trials provide insight into their safety profiles, real‐world data on dermatologic ADRs are limited. We conducted a retrospective pharmacovigilance analysis of the WHO VigiAccess database, examining individual case safety reports (ICSRs) for seven BRAF and MEKi up to May 2025. Disproportionality analyses (reporting odds ratio (ROR), proportional reporting ratio (PRR), with 95% confidence intervals (CIs)) were performed for high‐frequency dermatologic ADRs. Shannon entropy was used to assess the diversity of toxicity profiles across agents. Among 72,720 ICSRs, skin‐related ADRs accounted for 39.78% of reports with vemurafenib, 16.49% with dabrafenib, and 14.62% with encorafenib. Among MEKi, the proportion of skin‐related ADRs was highest for selumetinib (40.03%) and cobimetinib (34.31%). Rash was the predominant ADR across agents, but selumetinib demonstrated a significant disproportionality for dermatitis acneiform (ROR = 6.46, 95% CI [5.10, 8.18]). Photosensitivity reactions were most frequently reported with vemurafenib (11.31%) and cobimetinib (12.02%). Shannon entropy analysis identified two groups with differing ADR profile diversity: a higher‐diversity group (cobimetinib, H = 3.66; dabrafenib, H = 3.60) and a lower‐diversity group (trametinib, H = 3.51; binimetinib, H = 3.47); all cross‐group comparisons were statistically significant after Holm‐Bonferroni correction ( p < 0.05). Chi‐squared tests confirmed significant differences in skin ADR frequencies among agents (BRAF inhibitors: χ2 (2) = 1393.21, p < 0.001, Cramér's V = 0.255; MEKi: χ2 (3) = 1129.77, p < 0.001, Cramér's V = 0.175), with effect sizes indicating clinical relevance. Cutaneous ADRs are a defining toxicity of MAPK pathway inhibitors, with substantial interagent variability in frequency and phenotype. Real‐world pharmacovigilance data underscore the necessity for agent‐specific dermatologic monitoring strategies. Clinical pharmacists play a pivotal role in early ADR detection and management, enhancing adherence and optimizing therapeutic outcomes.

01 Jul 2026·GYNECOLOGIC ONCOLOGY

Primary ovarian malignant melanoma: A systematic review of cases and pooled analysis

Review

Author: Bowden, Sarah J ; Oikonomou, Maria D ; Ellis, Laura Burney ; Seckl, Michael J ; Kechagias, Konstantinos ; Shearer, Amy Macdonald ; Fotopoulou, Christina ; Kaur, Baljeet ; Kyrgiou, Maria ; Pandraklakis, Anastasios

OBJECTIVE:

Primary ovarian malignant melanoma is a rare malignancy arising from malignant transformation of a mature cystic teratoma of the ovary. Evidence is limited to case reports and case series. This systematic review and pooled analysis summarise clinical characteristics, management strategies and outcomes of this rare disease.

METHODS:

Systematic searches of Medline (PubMed), EMBASE, Scopus and Web of Science were conducted from inception to September 2025 identifying all case reports and case series reporting primary ovarian malignant melanoma. Data extraction and risk of bias assessments were performed in duplicate. Risk of bias was assessed using the Joanna Briggs Institute tool. Survival associations were analysed using Kaplan-Meier methods and Cox proportional hazards regression.

RESULTS:

Seventy-six studies reporting 92 patients were included. Mean age at diagnosis was 50.6 years (range 11-86). Abdominal distension (34/73, 46.6%) and pain (32/73, 44.4%) were the commonest presenting symptoms. Almost half were diagnosed International Federation of Gynaecology and Obstetrics stage I (34/70, 48.6%); no cases of stage II; 30% (21/70) were stage III and 15/70 (21.4%) stage IV. Surgery was performed in 78/79 (98.7%) patients. Adjuvant therapies included chemotherapy (35/63, 55.6%), immunotherapy (17/63, 27.1%), radiotherapy (9/63, 14.3%), and targeted therapy (3/63, 4.8%), including imatinib, vemurafenib and aflibercept regimes. Median overall survival declined with advancing stage (p-value <0.01); 62% of patients died (37/60), with 57.8% doing so within 12 months of diagnosis (21/37). In an unadjusted analysis, immunotherapy appeared associated with improved overall survival (Hazard Ratio [HR] = 0.38, 95% CI: 0.17-0.86, p-value = 0.02). This was not significant when restricted to stage 1 disease.

CONCLUSION:

Primary ovarian malignant melanoma is associated with poor prognosis across all disease stages. Our findings are descriptive, limited by the rarity of the disease and quality of existing evidence. International collaborative studies, rare cancer registries, and molecular profiling are essential to improve understanding and management.

01 Jul 2026·PHOTODERMATOLOGY PHOTOIMMUNOLOGY & PHOTOMEDICINE

Erlotinib and Leflunomide Disrupt 6‐Formylindolo[3,2‐ b ]Carbazole Metabolism and Sensitize Keratinocytes to UVA Radiation‐Induced Apoptosis

Article

Author: Hartung, Frederick ; Ramamoorthy, Samhita ; Dairou, Julien ; Rolfes, Katharina M. ; Meller, Stephan ; Haarmann‐Stemmann, Thomas

ABSTRACT:

Background/Purpose:

Phototoxicity is a common adverse effect triggered by systemic or topical drug treatments. It is mainly caused by drug‐induced sensitization to UVA radiation, arising from either the drug's inherent photosensitizing potential or its interference with the metabolism of endogenous photosensitizers. A potent endogenous UVA sensitizer is 6‐formylindolo[3,2‐ b ]carbazole (FICZ), a tryptophan photoproduct formed in UVB‐irradiated epidermal cells. By sequentially activating the aryl hydrocarbon receptor signaling pathway and inducing cytochrome P450 (CYP) 1A1 expression, FICZ induces its own degradation. Recently, we reported that the BRAF inhibitor vemurafenib interferes with CYP1A1 activity and sensitizes keratinocytes to FICZ/UVA‐induced phototoxicity. Herein, we screened 12 clinical drugs, known to exhibit phototoxicity in patients, for their potential to interfere with the metabolism of (exogenous) FICZ and sensitize HaCaT keratinocytes to UVA‐induced phototoxicity.

Methods:

The UV–VIS absorption of the drugs was determined, and their effect on CYP1A1 activity and FICZ/UVA‐triggered apoptosis was assessed in immortalized and primary human keratinocytes using 7‐ethoxyresorufin‐O‐deethylase (EROD) and caspase‐3 activity assays. Moreover, the impact of the candidate drugs on the metabolic degradation of FICZ in cells (LC analysis) as well as on the generation of oxidative stress (MitoSOX assay, qPCR analyses) was investigated.

Results:

We identified two drugs, erlotinib and leflunomide, to sensitize human keratinocytes to FICZ/UVA‐induced apoptosis by inhibiting CYP1A1 activity. Moreover, both drugs attenuated the metabolic breakdown of FICZ, enhanced the FICZ/UVA‐triggered formation of mitochondrial superoxide anions, and increased heme oxygenase‐1 (HMOX1) transcript levels, indicative of antioxidant defense activation.

Conclusion:

Disruption of FICZ metabolism may contribute to the phototoxicity of drugs.

News (Medical) associated with Vemurafenib

11 Jun 2026

·www.biospace.com

FDA Grants Priority Review for Genentech’s Tecentriq for a Certain Type of Stage III Colon Cancer

Filing acceptance is based on the Phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone Nearly one in three patients with stage III colon cancer relapse within five years, highlighting a critical need for new adjuvant treatment options If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- $RHHBY --Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq ® (atezolizumab) and Tecentriq Hybreza ® (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumor characterized by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by October 9, 2026. “This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.” "One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options,” said Michael Sapienza, CEO, Colorectal Cancer Alliance. “This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence." The application is based on the landmark ATOMIC study, recently published in The New England Journal of Medicine . ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, determined by an immunohistochemistry test, such as the VENTANA ® MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety pro consistent with previous studies of Tecentriq and FOLFOX6. Colon cancer remains one of the world's most common and deadliest tumors. Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage III patients relapse within five years. Approximately 15% of colon cancer patients present with dMMR/MSI-H tumors, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy. The ATOMIC study was sponsored by the National Cancer Institute (NCI) and conducted by the Alliance for Clinical Trials in Oncology in partnership with Genentech and the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. It highlights Genentech’s commitment to working alongside leading academic groups to tackle some of the most challenging cancers. About the ATOMIC study ATOMIC (A021502, NCT02912559 ) is a Phase III, randomized, open-label, multicenter study investigating the addition of Tecentriq ® (atezolizumab) to FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomized 1:1 to receive either FOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or FOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS). About Tecentriq ® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. What are Tecentriq and Tecentriq Hybreza? Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer: to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and your cancer tests positive for “PD-L1”. Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer: has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you. Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma: has spread to other parts of the body or cannot be removed by surgery. Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. It is not known if Tecentriq Hybreza is safe and effective when used: in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: in children younger than 2 years of age for the treatment of ASPS. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects. Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza. You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq Hybreza when used alone include: feeling tired or weak muscle or bone pain cough shortness of breath decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include: high blood pressure feeling tired or weak too much protein in the urine The most common side effects of Tecentriq and Tecentriq Hybreza when used in melanoma with cobimetinib and vemurafenib include: skin rash joint, muscle, or bone pain feeling tired or weak liver injury fever nausea itching swelling of legs or arms mouth swelling (sometimes with sores) low thyroid hormone levels sunburn or sun sensitivity The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is: urinary tract infection Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza. You may report side effects to the FDA at 1-800-FDA-1088 or . You may also report side effects to Genentech at 1-888-835-2555. Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information. About Genentech Oncology For more than 30 years, Genentech has pioneered oncology breakthroughs and is working to build a future where people with cancer can thrive, in spite of their diagnosis. With our therapies, we are intercepting disease where there is potential to deliver the best outcomes, while striving for longer-term impact in hard-to-treat settings. Our therapies are designed for the real world—reducing treatment burden and ensuring innovative care reaches patients who need them most, wherever they are. By working in lockstep with the medical, scientific, and patient communities, we are shaping the next era of cancer care. About Genentech Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit . Contacts Media Contact: Stella Belonwu (650) 467-6800 Advocacy Contact: Mychalleah Werner (650) 296-6218 Investor Contacts: Loren Kalm (650) 225-3217 Bruno Eschli +41 61 687 5284

Phase 3Clinical ResultImmunotherapyPriority ReviewDrug Approval

27 May 2026

·www.prnewswire.com

Immunic Appoints Distinguished Biopharmaceutical Executive Erik Lundgren as Chief Executive Officer

– Proven Leader with Deep Multiple Sclerosis Expertise; Played Key Role in the Launch of Ocrevus® – – Will Leverage Senior Global Executive and Commercial Experience to Support Immunic's Transition Toward a Commercial-Stage Multiple Sclerosis Company – NEW YORK, May 27, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of distinguished biopharmaceutical executive Erik Lundgren as Chief Executive Officer, effective May 22, 2026, with employment beginning on June 1, 2026. Mr. Lundgren succeeds Daniel Vitt, Ph.D., who will retain responsibility for scientific strategy and portfolio advancement while remaining a member of Immunic's Board of Directors. Mr. Lundgren will lead Immunic as the company advances vidofludimus calcium through late-stage clinical development, including the pivotal phase 3 ENSURE program in relapsing multiple sclerosis (RMS) and the planned phase 3 program in primary progressive multiple sclerosis (PPMS), while also preparing for potential new drug application (NDA) filing, regulatory approval and commercialization. "Immunic has evolved into a global late-stage biotechnology company built around its lead asset, vidofludimus calcium, which we believe represents one of the most compelling and differentiated opportunities in multiple sclerosis (MS) today," stated Michael W. Bonney, Chair of Immunic's Board of Directors. "As we look to our next phase of growth, including the pivotal phase 3 RMS data readout expected by year-end, preparations for NDA filing in this indication and potential commercialization thereafter, Erik's experience will be invaluable. I look forward to working with him as we continue transitioning Immunic toward a commercial-stage neurology company and deliver a potential next-generation treatment option for people living with MS." "I am truly honored to be joining Immunic at such an exciting and pivotal moment," stated Mr. Lundgren. "Over the past decade, the treatment landscape for MS has advanced meaningfully, broadening what is possible for people living with this complex disease. Yet a large unmet need remains, particularly for treatment options with the potential to slow disability progression and preserve neurological function. Vidofludimus calcium's potential to treat MS by targeting both immunological and neuroprotective pathways, along with a safety and tolerability profile that appears favorable to date, offers a differentiated approach within the MS therapeutic landscape, with the chance to impact both relapsing and progressive forms of the disease. Having spent my career focused on bringing innovative medicines to patients, including those with MS, I believe Immunic is uniquely positioned to advance this important program through late-stage development and potential commercialization. I look forward to working alongside the talented team at Immunic to help realize that vision." "Erik is highly accomplished and possesses the strategic, operational and commercial know-how needed to steer Immunic at this critical juncture," added Dr. Vitt. "His deep expertise in MS, including his role in helping shape the launch of Ocrevus®, combined with his long tenure and broad experience across Genentech and Roche, will be instrumental as we advance vidofludimus calcium through the pivotal phase 3 ENSURE readout in RMS and continue preparations for our planned phase 3 program in PPMS. As we approach these important milestones and continue our evolution toward becoming a commercial-stage biotechnology company, I am convinced that Erik is the right leader to guide Immunic into its next chapter. I look forward to continuing to support the company's scientific strategy and working alongside Erik and the Board to realize the full potential of our pipeline." Mr. Lundgren brings nearly two decades of biopharmaceutical experience spanning commercial strategy, product launches, global portfolio leadership, marketing and general management, with particular expertise in MS. He most recently served as Senior Vice President, Commercial Portfolio Organization at Genentech (a member of the Roche Group), where he led and oversaw the commercial strategy across all therapeutic areas of the company's broad portfolio. Prior to this role, he served as General Manager of Roche Czech Republic, where he led full operations and commercial strategy. Earlier, he served as Lifecycle Leader for Huntington's disease within Roche's neuroscience portfolio. Mr. Lundgren spent more than a decade at Genentech in roles of increasing responsibility, including serving as Senior Marketing Director supporting the launch and commercialization of Ocrevus® (ocrelizumab), a foundational treatment for RMS and PPMS and one of the most successful launches in neurology. He also held commercial leadership roles supporting the launches of oncology medicines, including Kadcyla® (ado-trastuzumab emtansine) and Zelboraf® (vemurafenib), and led various sales teams within Genentech's oncology franchise. Mr. Lundgren earned his Bachelor of Arts in Public Policy from Duke University and his Master of Business Administration from Harvard Business School. The Compensation Committee of Immunic's Board of Directors granted Mr. Lundgren an initial equity option to purchase 1,000,000 shares of common stock of the company under the Immunic, Inc. 2026 Inducement Equity Compensation Plan (the "Options"). The Options were granted as an inducement material to Mr. Lundgren's commencement of employment pursuant to NASDAQ Listing Rule 5635(c)(4). The Options will be time vested, with 25% vesting on the one-year anniversary of May 22, 2026 and the remainder vesting on a monthly basis in 36 equal installments. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the appointment of Mr. Lundgren and his integration into the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomic trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

Executive ChangePhase 3Phase 2

26 May 2026

·www.biospace.com

All eyes on Revolution, bispecific antibodies and more at ASCO26

iStock, Iryna Olkhova Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care. The upcoming American Society of Clinical Oncology annual conference will showcase data that could move the needle for some hard-to-treat cancers and those for which advances have been dormant for decades. Some 40,000 attendees from around the world will gather from May 29 to June 2 at Chicago’s McCormick Place Convention Center to present and discuss the latest innovations in cancer care. The 2026 ASCO meeting will include more than 7,000 abstracts, with studies exploring cutting-edge therapies that experts say could reshape the industry and patient care. “ASCO 2026 is shaping up to be one of the most exciting meetings in years for gastrointestinal oncology,” Allyson Ocean, a medical oncologist at NewYork-Presbyterian and Weill Cornell Medicine, told BioSpace in an email. “For pancreatic cancer specifically, there is a palpable sense at this year’s ASCO that we may be entering a fundamentally different era.” Elsewhere, experts are awaiting data on bispecific antibodies, as well as potentially practice-changing presentations in prostate, lung and blood cancers. Pancreatic cancer in the spotlight Heading into ASCO 2026, all eyes are on Revolution Medicines and pancreatic cancer . The company scored a plenary session spot at the conference for the Phase III RASolute 302 trial, evaluating its RAS inhibitor daraxonrasib against chemotherapy in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Revolution stunned the cancer world last month when topline data revealed that the pill nearly doubled overall survival , an unprecedented win in a disease with just a 13% 5-year relative survival rate. “This is a huge moment in pancreas cancer,” said Meredith Pelster, associate director of Gastrointestinal Cancer Research at Sarah Cannon Research Institute, who is an investigator on the RASolute trial but not an author on the plenary abstract. “You can feel the excitement.” Daraxonrasib is an oral drug that targets RAS mutations, common in PDAC, non-small cell lung cancer (NSCLC) and colorectal cancer. Patients in RASolute taking daraxonrasib had a median overall survival of 13.2 months, compared to 6.7 months for those on chemotherapy, according to Revolution’s press release . The company’s shares rallied 40% the day of the announcement. Additional RASolute data will be presented on Sunday, and experts are eager for information on the depth of the response, results based on patients’ specific mutations, and more. Pelster is looking to learn more about toxicities, after earlier data showed that the vast majority of patients developed a rash and around 30% had serious side effects. “We just want to understand that, so that we can counsel the patients and know how to manage it appropriately,” Pelster told BioSpace in an interview. Pancreatic cancer Can Revolution’s ‘miracle’ pancreatic cancer drug be topped? Immuneering, Actuate say yes Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients. May 18, 2026 · 7 min read · Heather McKenzie Read more Adding to the buzz around the gastrointestinal space is the deployment of blood tests for circulating tumor DNA (ctDNA) to help manage patient care. A notable late-breaker will discuss the CIRCULATE trial, which tested using ctDNA to guide decisions for adjuvant treatment in stage II colon cancer. The strategy could spare some patients unnecessary chemotherapy while flagging others who might need more treatment, Ocean said. This year’s ASCO reflects a broader shift toward biomarker-driven precision oncology for gastrointestinal cancers, Ocean said. Other anticipated presentations in the space include trials looking at Pfizer’s Braftovi plus cetuximab and chemotherapy in colorectal cancer, Shanghai KeChow Pharma ’s Tunlametinib plus vemurafenib in colorectal cancer, and Incyte’s Pemazyre in bile-duct cancer. Bispecifics and HARMONi-6 For Leerink Partners analyst Daina Graybosch, the focus is on bispecific antibodies, particularly the Keytruda rival ivonescimab, in development by Summit Therapeutics and its Chinese partner Akeso. Akeso’s closely watched Phase III trial HARMONi-6 also claimed a spot in ASCO’s plenary session. The trial puts the PD-1/VEGF bispecific ivonescimab plus chemotherapy up against BeOne Medicines’ Tevimbra plus chemotherapy as first-line treatment for patients with advanced squamous NSCLC. The session comes on the heels of positive progression-free survival (PFS) data presented at the European Society for Medical Oncology Congress in October 2025. Median PFS was 11.14 months for patients treated with the ivonescimab combo compared to 6.9 months in the comparator group. “The big debate is, what does this look like in overall survival?” Graybosch, senior managing director of immuno-oncology at Leerink, said in an interview with BioSpace . That answer will help determine where ivonescimab and other bispecifics fit in the treatment landscape, she said. “For me, it’s: How much better than Keytruda is it going to be?” Graybosch added. “Then, what does that mean in terms of who is going to have sustainable revenues from a bispecific?” Ivonescimab has the potential to shake up the therapeutic status quo, in which Merck’s blockbuster PD-1 inhibitor Keytruda currently reigns supreme. The asset grabbed attention when it bested Keytruda i n a China-only trial in 2024 in advanced NSCLC. But more recent global trials have missed their marks on PFS overall survival, tempering expectations and raising questions about ivonescimab’s global potential. Lung Cancer Summit’s Bispecific Misses Survival Endpoint in Global Phase III Trial but Analysts Remain Optimistic Despite mixed results, analysts maintained faith in ivonescimab’s ability to cross over between Eastern and Western patient populations. May 30, 2025 · 3 min read · Nick Paul Taylor Read more This puts even more pressure on the overall survival data for HARMONi-6, a China-only trial, that will be presented this weekend, Graybosch said. “If you believe that the data is going to degrade in effect from China to a global study, you need to see a really impressive result in China.” Other companies are also showcasing data on PD-1/VEGF bispecifics this weekend. Bristol Myers Squibb and BioNTech have Phase 2 data in NSCLC and Phase 2/3 data in colorectal cancer for their bispecific PD-1/VEGF-A inhibitor pumitamig. Pfizer, meanwhile, has updated Phase 2 data for its PD-1/VEGF bispecific antibody in patients with NSCLC. Practice-changing potential In addition to RASolute302 and HARMONi-6, the other plenary session slots at this year’s ASCO have the potential to shift practice for both common and rare cancers, experts said. One such trial could help determine whether oncologists should add Johnson & Johnson’s androgen receptor inhibitor ERLEADA before and after surgery for patients with high-risk localized prostate cancer. The LIBRETTO-432 trial will analyze event-free survival with Eli Lilly’s Retevmo in stage IB-IIIA RET fusion-positive NSCLC in the adjuvant setting, to see whether the drug should move from advanced to earlier-stage disease. And the Phase III SARC041 trial is testing Lilly’s CDK4 inhibitor Verzenio in a rare, difficult-to-treat sarcoma called dedifferentiated liposarcoma (DDLS). Another notable late-breaker with the potential to change practice is a Phase III study of Incyte’s anti-CD19 monoclonal antibody Monjuvi/Minjuvi plus lenalidomide and R-CHOP chemotherapy vs. current R-CHOP standard of care in newly diagnosed patients with diffuse large B cell lymphoma (DLBCL). “The first-line treatment of diffuse large B cell lymphoma has not been changed for a couple of decades,” Andres Sirulnik, head of the Hematology Clinical Development Unit at Regeneron, told BioSpace . “People are waiting to see the results.” Regeneron is presenting its own data in frontline DLBCL, an early readout of its bispecific antibody Ordspono plus chemotherapy in the Phase III OLYMPIA-3 trial. The treatments could offer patients a shorter, less cumbersome regimen, Sirulnik said. “We are hoping that this also will translate to better outcomes.”

Phase 3ASCOClinical ResultPhase 2

100 Deals associated with Vemurafenib

External Link

KEGG	Wiki	ATC	Drug Bank
D09996	Vemurafenib	L01XE15	DB08881

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
BRAF mutation positive Melanoma	Japan	Chugai Pharmaceutical Co., Ltd.	26 Dec 2014
BRAF V600 mutation-positive Melanoma	European Union	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Iceland	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Liechtenstein	Roche Registration GmbH	17 Feb 2012
BRAF V600 mutation-positive Melanoma	Norway	Roche Registration GmbH	17 Feb 2012
Melanoma	United States	Hoffmann-La Roche, Inc.	17 Aug 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
BRAF V600E mutant Colorectal Cancer	Phase 3	China	-	25 Oct 2023
Anaplastic Thyroid Carcinoma	Phase 3	United Kingdom	-	01 Mar 2023
BRAF V600 mutation-positive Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	01 Mar 2023
Erdheim-Chester Disease	Phase 3	United Kingdom	-	01 Mar 2023
Glioma	Phase 3	United Kingdom	-	01 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Laryngeal Neoplasms	Phase 3	United Kingdom	-	01 Mar 2023
Multiple Myeloma	Phase 3	United Kingdom	-	01 Mar 2023
Non-Small Cell Lung Cancer	Phase 3	United Kingdom	-	01 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03224767 (ALLIANCE A071601, CTgov)	Phase 2	Craniopharyngioma \| BRAF V600E mutation-positive low grade glioma	24	cobimetinib+vemurafenib (Arm A)	yunvryrwee = jegugrstgn ojataibady (qucvexyxuv, erdmggxicq - jjsyhnwnrw) View more	-	10 Jun 2026
				cobimetinib+vemurafenib (Arm B)	yunvryrwee = pnksfeilis ojataibady (qucvexyxuv, jrtwixxaee - nbeqwensng) View more
NCT02968303 (COWBOY, ASCO2026)	Phase 2	BRAF V600E Mutation-Positive Melanoma BRAF V600E/K mutation	71	Vemurafenib 960 mg bid + Cobimetinib 60 mg QD + Vemurafenib 960 mg bidk +Cobimetinib 60 mg QD3wk	qhtouyyvas(frvicsarnt) = In arm A, the BOR was partial response (PR) in 75% of the pts (36.1% had an ongoing response after treatment switch), stable disease (SD) in 22.2%, and progressive disease (PD) in 2.8%. In arm B, 54.3% had PR, 22.9% SD, and 20% PD (1 pt was not evaluable). kkurxjyptw (ghhgfcmycu ) View more	Negative	29 May 2026
				Ipilimumab 3 mg/kg q3wk + Nivolumab 1 mg/kg q3wk
NCT03554083 (NeoACTIVATE, ASCO2026)	Phase 2	Melanoma Neoadjuvant BRAF status	30	atezolizumab, vemurafenib, cobimetinib (BRAF-mutated)	hcybhhohui(dhsgethfis) = dbsruvusai hvqwxbdgno (rblhsrlnbd, 48 - 86.3) View more	Positive	29 May 2026
ASCO2026	Not Applicable	BRAF V600E Mutation-Positive Melanoma First line BRAF-mutant	790	Dabrafenib + trametinib (D+T)	mckyteqyxk(dakogwdqfb) = wmumznmlmp wbzortmsjd (gdtlnbgneh, 7.33 - 9.33) View more	Positive	29 May 2026
				encorafenib + binimetinib (E+B)	mckyteqyxk(dakogwdqfb) = wvzvjufaej wbzortmsjd (gdtlnbgneh, 7.95 - 12.42) View more
EHA2026	Phase 2	Hairy Cell Leukemia	19	Vemurafenib+Cobimetinib	tosrizbgrg(plegcaaoex) = dzdktwtzoh ixhpifzhda (fdlixhkocs ) View more	Positive	12 May 2026
				Vemurafenib+Cobimetinib (V+C+O)	tosrizbgrg(plegcaaoex) = bycoyvjvbw ixhpifzhda (fdlixhkocs ) View more
EHA2026	Not Applicable	Histiocytosis, Non-Langerhans-Cell \| Histiocytosis, Langerhans-Cell	5	Cytarabine	gzizfpzpvv(kefpmnasyz) = zjsqxmylnp jlgpeshrat (kkouxhyblu ) View more	Positive	12 May 2026
				Vemurafenib	citciwtnfu(aimwsoqlyl) = qagjnnpgtb crprureegd (mmozaofidy )
NCT03554083 (NeoACTIVATE \| NeoACTIVATE arm C, CTgov)	Phase 2	Melanoma, Cutaneous Malignant	64	Atezolizumab+Tiragolumab	hplzcqxykr(gtssqfivkt) = xpwkqbpsoj kxbjtlzday (ofnmitdzid, tockrtizpi - nmuqplilbg) View more	-	04 May 2026
NCT05068752 (Pubmed \| J Immunother Precis Oncol)	Phase 2	KRAS Mutant Pancreatic Cancer KRAS mutations	9	Vemurafenib and Sorafenib combination	oifsjghxpj(xpfeygdzcp) = eiqujfptzl kpmtybiiuv (oryjiqnwgt ) View more	Negative	10 Feb 2026
NCT05019534 (Pubmed \| J Transl Med)	Phase 1	BRAF V600E mutant Colorectal Cancer Second line BRAF V600E \| microsatellite stable (MSS)	12	Vemurafenib+cetuximab+camrelizumab	oghwvxsqbe(gavyjroeya) = mplgknbtke rlolgoaskg (edjgnfzftg ) View more	Positive	12 Nov 2025
NCT01711632 (CTgov)	Phase 2	Hairy Cell Leukemia	36	Vemurafenib	zecbqezzvi = qcghqnudem zvnwcudvmb (uabpjtsnkh, pauqnuzccn - deafhomxlb) View more	-	20 Oct 2025

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