Camizestrant

iStock, designer491 BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer. BioNTech, Summit Therapeutics, GSK and Roche have made a splash already at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer. BioNTech and OncoC4 report OS win for CTLA-4 drug Ahead of its upcoming pivotal readout, BioNTech shared overall survival (OS) data for gotistobart, a next-gen anti-CTLA-4 monoclonal antibody in development with OncoC4. The investigational drug elicited a median OS of 18.5 months for patients with metastatic squamous NSCLC (sqNSCLC) that had progressed after prior treatment, versus the 10-month median for patients on chemotherapy. The data are from the non-pivotal stage of the global PRESERVE-003 Phase 3 trial, designed to confirm the correct dose for the second portion of the study, which is currently ongoing, with an interim readout expected sometime this year. The new findings are the first median OS results to be shared for gotistobart and build off “encouraging” 12-month OS data published in March, at which point median OS had not been reached. The most recent data further confirm the antibody’s survival advantage over chemotherapy, BMO analysts wrote Monday, with the improvement indicating the “potential for non-chemotherapy-based treatment in sqNSCLC.” Summit and Akeso provide more positive OS data for ivonescimab Summit Therapeutics and China-based partner Akeso shared another ivonescimab readout, this time demonstrating a 27% death risk reduction for patients with PD-L1-positive advanced non-small cell lung cancer (NSCLC) compared to Keytruda, Merck’s blockbuster PD-1 inhibitor. The Phase 3 HARMONi-2 trial showed statistically significant OS benefit for patients receiving the investigational bispecific antibody compared to Keytruda monotherapy. Conducted in China, the trial continued to demonstrate “an acceptable and manageable safety profile,” Summit said in a Sunday release. Ivonescimab’s survival benefit over Keytruda “show some additional class benefit,” BMO analysts wrote in a Monday note. Earlier this month, Summit and Akeso announced that the HARMONi-2 study demonstrated a statistically significant OS advantage over standard-of-care—thereby meeting a key secondary endpoint of the trial—but didn’t provide the data behind the claim. Now, the companies have shared that ivonescimab achieved a hazard ratio (HR) of 0.73, with patients on the investigational drug achieving median OS of 30.8 months, compared with 22.6 months for those taking Keytruda. BMO highlighted the fact that HARMONi-2 is a Chinese patient population study, “limiting interpretation to Western trials, but results still read positively to future PD-(L)1/VEGF bispecific development”—such as pumitamig from BioNTech and BMS. “We look to global data from the HARMONi-3 trial in sqNSCLC for a better assessment of this efficacy advantage in a non-Chinese selective population,” BMO wrote. Akeso secured China approval for ivonescimab based on the primary results of HARMONi-2 in April 2025. The drug demonstrated a statistically significant 49% improvement in progression-free survival (PFS) when compared to Keytruda. “HARMONi-2 is the fourth Phase 3 study of ivonescimab to demonstrate statistically significant improvements for both overall survival and progression-free survival in head-to-head comparisons against standard-of-care regimens,” Summit co-CEO Robert Duggan said in a Sunday release. Lung cancer Summit and Akeso sharpen case for ivonescimab with new Western data Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant. July 22, 2026 · 2 min read · Gabrielle Masson Read more GSK and Hansoh’s ris-rez hits 8 month survival advantage GSK and China partner Hansoh Pharma shared a median OS of 18.5 months for risvutatug rezetecan (ris-rez), which reduced death risk by 54% compared to standard-of-care that was tied to an OS of 10.3 months. The Phase 3 study included patients in China with relapsed small cell lung cancer (SCLC) that had progressed after platinum-based first-line therapy, with the statistically significant reduction scoring a primary endpoint win. Patients receiving ris-rez also experienced fewer severe treatment-related side effects (TRAEs) than those on chemotherapy, with grade 3 or higher TRAEs occurring in 60.9% of participants compared to 78.2% of people in the control group. The companies previously shared that the B7-H3 ADC had met the study’s main goal but didn’t share specifics at the time. GSK paid $185 million in December 2023 to secure exclusive global rights to ris-rez outside of China, Hong Kong, Macau and Taiwan in a deal that could max out at $1.7 billion. The pharma is advancing the ADC across lung cancer, prostate cancer and other solid tumors, with pivotal data in relapsed extensive-stage SCLC expected next year. Roche and MediLink’s tam-peli heading to Phase 3 Roche and China partner MediLink Therapeutics’ antibody drug conjugate (ADC) tambotatug pelitecan (tam-peli) scored in a Phase 3 small cell lung cancer (SCLC) with a median OS of 13.3 months . That’s significantly longer than the 9.4 OS for patients receiving standard-of-care treatment, translating to a 54% reduced risk of death for patients taking tam-peli. Tam-peli showed a “favorable and manageable safety profile,” Roche said. The drug demonstrated lower rates of grade 3 or higher treatment-related adverse events (TRAEs) compared to chemotherapy, at 46.4% incidence compared to 74.7%. Treatment-emergent interstitial lung disease across all grades was reported in 4.9% of tam-peli patients compared to 1.4% for standard of care, with no grade 4 or 5 events reported in either group. The data support Roche’s plans to launch global Phase 3 trials for tam-peli, the pharma said. The ADC has nabbed FDA Breakthrough Therapy designation in SCLC. Breast cancer AstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger market SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug. September 14, 2026 · 2 min read · Tristan Manalac Read more

AstraZeneca's Etcamah (camizestrant) has fallen short in a Phase III study testing whether the oral selective oestrogen receptor degrader (SERD) could outperform an aromatase inhibitor when used as an upfront treatment for advanced ER-positive, HER2-negative breast cancer.In the SERENA-4 trial, AstraZeneca said Etcamah plus Pfizer's Ibrance (palbociclib) produced a "numerical improvement" on the primary endpoint of progression-free survival versus anastrozole plus Ibrance, but the difference wasn't statistically significant.The result comes a week after the FDA granted Etcamah accelerated approval for use as part of biomarker-triggered switching strategy in which patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer are given the drug when an ESR1 mutation emerges during aromatase inhibitor (AI) plus CDK4/6 inhibitor therapy (see – Physician Views Preview: Can AstraZeneca's Etcamah carve out a new treatment paradigm in breast cancer?). That decision was based on data from the Phase III SERENA-6 study."Whilst we are disappointed by the SERENA-4 outcome, it sharpens our focus on maximising the number of patients who can benefit from Etcamah today based on SERENA-6 and reinforces the importance of ESR1 testing for patients on first-line therapy," said Susan Galbraith, EVP for Oncology Haematology R&D at AstraZeneca, in a release Friday."Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader programme," she added.Echoes of Roche rivalSERENA-4 enrolled 1371 adult patients with newly diagnosed Stage IV de novo or recurrent disease who had not received systemic treatment for advanced disease. The trial was testing whether replacing the AI component of standard first-line treatment with Etcamah could improve outcomes, with all patients also receiving Ibrance. Secondary endpoints include overall survival and PFS2.AstraZeneca said the safety profile was consistent with the known profiles of the individual drugs, with no new safety concerns, and that full data would be shared in due course.The result puts Etcamah in similar territory to Roche's rival oral SERD giredestrant, which also failed to significantly improve PFS in the Phase III persevERA trial toplined in March. That study compared giredestrant plus Ibrance with letrozole plus Ibrance in 992 patients receiving first-line treatment; it had also shown a numerical PFS improvement, but missed statistical significance.At this year's American Society of Clinical Oncology meeting, Roche reported median PFS was 33.1 months with giredestrant versus 28.2 months with letrozole, corresponding to a PFS benefit of 11% in favour of giredestrant (see – KOL Views Q&A: Breast cancer at ASCO – first take on AZ and Roche oral SERD debates, Gilead's Trodelvy TNBC data).'Manageable setback'RBC Capital analyst Trung Huynh called the SERENA-4 results a "manageable setback" that largely removes a near-term uncertainty without fundamentally altering the long-term investment case for Etcamah.James Gordon of Barclays likewise described the update as "well anticipated by the market," citing the earlier Roche failure as well as AstraZeneca's cautious commentary on SERENA-4.Earlier this year, Galbraith had highlighted a number of factors that could favour SERENA-4 over persevERA, including a first-line population enriched for endocrine sensitivity and a much larger patient population "sized for an effect size that will still be clinically meaningful in that population." For more, see – Spotlight On: First-line and adjuvant opportunities still beckon for AstraZeneca's camizestrant despite FDA setback.Meanwhile, AstraZeneca is also continuing to test Etcamah in earlier-stage disease in the Phase III CAMBRIA-1 and CAMBRIA-2 trials, which together are enrolling about 10,000 patients. The trials are designed for patients at both intermediate and high risk of recurrence in the adjuvant setting, evaluating Etcamah as monotherapy, together with CDK4/6 inhibitors and following CDK4/6 inhibitor treatment.According to Jefferies analysts, AstraZeneca estimates the drug could generate more than $5 billion in peak annual sales, with early breast cancer expected to account for most of that opportunity.