New MajesTEC-3 modeling from Johnson & Johnson finds that TECVAYLI plus DARZALEX FASPRO, used as early as second line, could give roughly 87% of relapsed/refractory multiple myeloma patients a mortality risk and life expectancy close to the general population, driven by a 90% drop in disease-progression risk versus standard of care.
Johnson & Johnson has reported pivotal Phase 3 findings for CAPLYTA (lumateperone) in bipolar mania, with the study showing significant and rapid improvement in manic symptoms.
Gilead Sciences accelerates global access planning for investigational once-yearly lenacapavir, expanding royalty-free generic licensing across 120 high-incidence countries alongside Phase 3 PURPOSE 365 trials.
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
GSK’s B7-H3-targeted ADC Ris-Rez cut the risk of death by 54% versus topotecan in the Phase III ARTEMIS-008 trial in relapsed small cell lung cancer in China, with a median overall survival of 18.5 months and fewer severe side effects than chemotherapy.
Kyowa Kirin KHK4951 eye drops missed their Phase 2 primary endpoint in neovascular age-related macular degeneration, though most patients maintained vision through Week 52 with no new safety signals in Study 4951-002.
Amgen’s Phase 3 DeLLphi-305 trial shows the IMDELLTRA Imfinzi combination delivers a statistically significant, clinically meaningful overall survival benefit as first-line maintenance therapy in extensive-stage small cell lung cancer, alongside gains in progression-free survival and response rate.
New two-year data from Roche’s Phase IIIb/IV SALWEEN trial show that Vabysmo (faricimab) delivers durable vision gains and disease control in Asian patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration, while cutting treatment visits for the majority of patients.
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
Roche’s next-generation KRAS G12C inhibitor, divarasib, has achieved statistical significance in a global head-to-head Phase III trial against sotorasib and adagrasib for advanced non-small cell lung cancer.
