Selpercatinib

SAN FRANCISCO, and SUZHOU, China, June 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) monotherapy and combo-therapy with bevacizumab in advanced colorectal cancer were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI363 demonstrated encouraging response and overall survival benefit in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, supports its unique mechanism of actions (MoA) of turning "cold tumor" into "hot tumor". Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2 α-bias bispecific antibody fusion protein IBI363 monotherapy and combined with bevacizumab in participants with advanced colorectal cancer: results from Phase 1 studies Two Phase 1 studies (NCT05460767, NCT06717880) were conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 monotherapy and combined with bevacizumab in patients with advanced colorectal cancer. IBI363 monotherapy has demonstrated breakthrough antitumor therapeutic potential, showing a significant extension of overall survival compared to data of standard-of-care therapies As of the data cutoff date (Apr 7th, 2025), a total of 68 participants with advanced colorectal cancer received IBI363 monotherapy at the dose levels from 0.1 mg/kg to 3mg/kg. No patients were confirmed as microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). 86.8% of patients were microsatellite stable (MSS) or proficient mismatch repair (pMMR). 61.8% of patients had liver metastases. 63.2% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 23.9% of patients had received prior immunotherapy. Notably, among patients receiving monotherapy with IBI363 (n=68), with a median follow-up time of 20.1 months, the median overall survival (OS) reached 16.1 months, demonstrating a significant improvement compared to the historical data of standard treatments (ranging from 6.4 to 9.3 months1-3). Subgroup analyses revealed that patients with or without liver metastasis both showed excellent overall survival (OS), indicating significant clinical benefit. The median OS were 14.4 months (with liver metastasis) and 17.0 months (without liver metastasis). Among patients treated with monotherapy of IBI363 1 mg/kg every 2 weeks (Q2W) (n=22), the confirmed objective response rate (cORR) was 13.6%. The combination of IBI363 and bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile, with excellent data on objective response rate and progression-free survival As of the data cutoff date (Apr 7th, 2025), a total of 73 patients with advanced colorectal cancer received IBI363 （dose levels from 0.6 mg/kg to 3mg/kg） and bevacizumab combination therapy. No patients were confirmed as MSI-H or dMMR. 91.8% of patients were MSS or pMMR. 56.2% of patients had liver metastases. 54.8% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 16.4% of patients had received prior immunotherapy. In all participants treated with IBI363 in combination with bevacizumab (n=73), the cORR was 15.1% and the disease control rate (DCR) was 61.6%. With a median follow-up time of 9.9 months, the median progression free survival (PFS) reached 4.7 months. W ith a median follow-up time of 9.4 months, OS was not mature, with events in only 13 participants (17.8%). As for the combination therapy in patients without liver metastases (n=32), the confirmed ORR was 31.3%, with a DCR of 81.3%. The median PFS reached to 7.4 months. In those participants who received IBI363 at 3 mg/kg Q3W plus bevacizumab (n=31), confirmed ORR and DCR increased to 19.4% and 71.0%, respectively. The median PFS increased to 5.6 months. In terms of safety, among participants receiving monotherapy and combination therapy, 19 (27.9%) and 26 (35.6%) reported treatment-related adverse events (TRAEs) of Grade 3 or higher, respectively. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. No new safety signals were observed, with a manageable risk-benefit profile in IBI363 alone or in combination with bevacizumab. Tumor immune cell infiltration analysis supports the IBI363 MOA of turning "cold tumor" into "hot tumor", demonstrating enrichment of PD1+CD25+CD8+ cells in baseline tumor tissue association with clinical efficacy In baseline tumor tissues, elevated infiltration of CD8+ cells, CD25+CD8+ cells, and PD1+CD25+CD8+ cells were associated with improved clinical response to IBI363 monotherapy (partial response or stable disease). This supports the potential anti-tumor effects of IBI363 in the treatment of colorectal cancer from the perspective of its mechanism of action. Professor Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: "Colorectal cancer is the third most common cancer type globally and ranks fourth in cancer-related mortality4. About 86% of colorectal cancer are in an immune 'desert' or immune-inflamed suppressed state, rendering traditional immune checkpoint inhibitors (ICIs) ineffective5. For colorectal cancer that has failed standard treatments, there are limited therapeutic options with short survival periods, representing a significant unmet clinical need6. IBI363, as a PD-1/IL-2α-bias bispecific fusion protein, has demonstrated robust antitumor efficacy in preclinical studies through the effective expansion of tumor-specific CD8⁺ T cells (TST cells). Its ability to block PD-1 and stimulate TST cells holds the potential to transform 'cold' tumors into 'hot' tumors. As a monotherapy, IBI363 achieves a median survival of 16.1 months in later-line treatments, which represents a significant improvement compared to the median survival of current standard therapies and also confirms its potential with a strong 'tail effect' as a PD1 plus cytokine bispecific immunotherapy. The combination of IBI363 with bevacizumab is still under continuous follow-up, having shown promising efficacy and tolerable safety, with unique efficacy characteristics particularly in the subgroup without liver metastasis. Overall, clinical data suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and warrants further exploration." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "On top of the preliminary data reported at 2024 ASCO and 2024 ESMO, we are presenting more updated follow-up data and combination therapy results of IBI363 at the ASCO Congress this year. From a comprehensive body of clinical evidence that includes ORR, PFS, OS, IBI363 demonstrated robust antitumor activity of both monotherapy and combination therapy in patients with advanced colorectal cancer who are non-MSI-H/dMMR. We are eyeing on long-term survival data from high dose in longer follow-up period. And the pivotal study of IBI363 targeting advanced CRC is in plan. Observing such results in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, further highlights the broad development potential of IBI363. It offers hope for expanding into areas where immunotherapy has been less effective or even unresponsive." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN FRANCISCO and SUZHOU, China, June 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc (Suzhou) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the data from Phase 1 and Phase 2 clinical studies of IBI363, first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for the treatment of "immune cold tumor" —immunotherapy-pretreated melanoma (acral and mucosal subtypes) were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI363 has shown breakthrough efficacy in patients with heavily-treated melanoma subtypes - which are traditionally treatment-resistant "cold" tumors, and a pivotal registration trial for IBI363 is currently ongoing. Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. A Phase 1/2 clinical study of PD-1/IL-2α-bia s bispecific antibody fusion protein (IBI363) in the treatment of advanced "cold" tumor subtypes (acral and mucosal) malignant melanoma The data presented at this ASCO meeting are from two multi-center Phase 1 and 2 clinical studies (registration no.: NCT05460767, NCT06081920) designed to evaluate the efficacy and safety of IBI363 monotherapy in the treatment of advanced melanoma. As of April 7, 2025, a total of 31 patients with unresectable, locally advanced or metastatic acral and mucosal melanoma who had previously received immunotherapy were enrolled and treated at the dosage of 1 mg/kg Q2W, and 64.5% of them had ≥2 lines of prior treatment. Breakthrough efficacy of IBI363 monotherapy has been achieved in patients with "immune-cold" melanoma, with notable durable response and prolonged survival benefit: In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type. In patients treated with 1 mg/kg Q2W with confirmed responses (n=7), a durable response was observed with a median duration of response (DoR) of 14.0 months and events of 42.9%. In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months [1] ). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months. The overall 12-month OS rate was 61.5%. In terms of safety, IBI363 was generally well tolerated. Among the subjects treated with 1 mg/kg Q2W (n = 31), the treatment-related adverse events (TRAEs) with an incidence > 30% were arthralgia, rash, and hyperthyroidism, most of which were Grade 1 or 2. The overall incidence of Grade ≥ 3 TRAEs was 29.0%, and only 3.2% of subjects discontinued treatment due to TRAEs. Overall safety was manageable, and no new safety risks were found. A pivotal Phase 2 registrational study of IBI363 in the treatment of advanced acral and mucosal malignant melanoma has been initiated Innovent Biologics announced a trial in progress (TiP) . It is a randomized, open-label, multi-center Phase 2 study evaluating the efficacy and safety of IBI363 monotherapy compared to pembrolizumab (Keytruda®) in patients with unresectable, locally advanced or metastatic mucosal and acral melanoma who have not received prior systemic treatment. As the first pivotal registration trial of IBI363, this study is designed to directly compare IBI363 monotherapy with pembrolizumab in this patient population. A total of 180 patients are planned to be enrolled and randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The first patient was dosed in March 2025, marking a significant step in advancing IBI363's development in melanoma. Additional studies exploring IBI363 in combination therapies across other cancer types are also ongoing. Professor Guo Jun from Peking University Cancer Hospital and the Principal Investigator of Melanoma Studies on IBI363 said: "Although melanoma is a relatively rare malignant tumor in China, it has a high mortality rate, and its incidence continues to rise each year. Historically, patients with melanoma who have not received immunotherapy have had a median PFS of only about 3 months, which highlights a significant unmet clinical need. Notably, non-cutaneous melanoma (especially mucosal melanoma) accounts for a large proportion of cases in China and is considered a 'cold tumor', typically unresponsive to traditional immunotherapy. In these cases, the response rate to PD-1 monotherapy is often below 15%, offering limited clinical benefit. More effective treatments are urgently needed[2]. IBI363 addresses this challenge by transforming 'cold tumors' into 'hot tumors' through dual activation of the PD-1 and IL-2 pathways. The data presented in this study showed that IBI363 delivers significantly improved efficacy compared to previous studies in cold tumor subtypes and standard of care therapies, while maintaining a favorable safety profile. IBI363 has the potential to become a new standard in immunotherapy for malignant melanoma in China, providing a long-needed treatment option for patients with acral and mucosal malignant melanoma." Dr. Zhou Hui, Senior Vice President of Innovent Biologics, said: "At present, there is a huge unmet clinical need for the treatment of unresectable, locally advanced or metastatic mucosal and acral melanoma in China. Approved PD-1 therapies have not substantially improved first-line outcomes in melanoma, and the clinical benefits remain limited[3]. IBI363 is leading the evolution of next-generation immunotherapy. By leveraging a dual-mechanism of 'PD-1 blockade + IL-2 directed activation', IBI363 enhances T cell function and expands T cell populations to reshape the tumor immune microenvironment. IBI363 has shown excellent efficacy and safety results in the treatment of patients with immune-cold melanoma subtypes. A Phase 2 pivotal registrational study is currently underway. Positive results in patients with mucosal and acral melanoma are highly anticipated, offering hope for a more effective treatment option. Meanwhile, we are accelerating the global development of IBI363 across multiple tumor types, with the goal of making this innovative treatment accessible to patients around the world." About Melanoma Melanoma is a malignant tumor that develops from melanocytes. While it accounts for only 3% of all skin cancers, it has the highest mortality rate and is the most prone to metastasis. In China, both the incidence and mortality rates of melanoma are rising annually. Based on tumor location, melanoma is classified into cutaneous, acral, and mucosal subtypes. Melanoma in Chinese populations differs significantly from that in Caucasian populations in Europe and the United States with regard to pathogenesis, biological behavior, histological morphology, treatment methods, and prognosis[4]. For patients with advanced cutaneous and acral melanoma with BRAF V600 mutation, a combination of BRAF and MEK inhibitors is the preferred treatment. For those without this mutation, chemotherapy combined with anti-angiogenic drugs is often considered as first-line treatment. Although pembrolizumab was approved in Sep. 2024 for first-line treatment of melanoma, the clinical benefit of PD-1 inhibitors in this setting remains modest. In second-line treatment, agents different from those used in the first line are generally preferred. For patients not previously treated with a PD-1 inhibitor, it can be considered as a second-line option. In advanced mucosal melanoma, median PFS for patients without prior immunotherapy is only about 3 months. Given the limited efficacy of current treatments for non-cutaneous melanomas, especially mucosal subtypes, which are more prevalent in China, there is an urgent need for more effective therapies. About IBI363 (PD-1/IL-2 α-bias bispecific antibody fusion protein) IBI363 is the world's first PD-1/IL-2α-bias bispecific fusion protein independently developed by Innovent Biologics. It integrates two key functions: blockade of the PD-1/PD-L1 pathway and activation of the IL-2 signaling pathway. The IL-2 arm of IBI363 has been engineered to retain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm enables simultaneous PD-1 blockage and selective delivery of IL-2. This differential targeting strategy exploits the fact that newly activated tumor-specific T cells co-express PD-1 and IL-2α, which allows for more precise and efficient targeting and activation of this T cell subset. IBI363 not only showed good anti-tumor activity in a variety of tumor-bearing pharmacological models but also showed prominent anti-tumor efficacy in PD-1 resistance and metastasis models. Driven by urgent clinical needs, Innovent Biologics is conducting clinical studies in China, the United States, and Australia to assess the efficacy and safety of IBI363 across multiple tumor types. The first pivotal registration trial of IBI363 has been initiated for the treatment of mucosal and acral melanoma without immunotherapy. IBI363 has been granted two fast track designations by the FDA for the treatment of advanced squamous non-small cell lung cancer and melanoma, respectively. IBI363 has also been granted Two Breakthrough Therapy Designations by the National Medical Products Administration (NMPA) for the treatment of advanced melanoma and squamous NSCLC. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. For more information, please visit the company's website: or the company's LinkedIn account. Statement: 1. Innovent Biologics does not recommend the use of unapproved drugs/indications. 2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company Forward-Looking Statement The information in this press release may contain certain forward-looking statements. These statements are inherently risky and uncertain. The use of the words "anticipate," "believe," "predict," "expect," "intend" and similar expressions in connection with the Company are intended to identify forward-looking statements. The Company is under no obligation to continually update these predictive statements. These forward-looking statements are based on the Company's management's existing views, assumptions, expectations, estimates, forecasts, and understandings of future matters at the time of the statements. These statements are not guarantees for future development and are subject to risks, uncertainties, and other factors, some of which are beyond the control of the Company and are difficult to predict. As a result, actual results may differ materially from those contained in such forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company, its directors and employee agents have no obligation to (a) correct or update any forward-looking statements contained in this Website; and (b) any liability arising from the fact that any forward-looking statements cannot be realized or are rendered incorrect. REFERENCES SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED