A phase 3 trial of the Roche-partnered, B7-H3-directed antibody-drug conjugate from MediLink hit its primary endpoint in small-cell lung cancer. The median overall survival benefit, however, fell short of the cross-trial bar set by GSK's rival B7-H3 asset, positioning MediLink and Roche behind GSK in this setting.
In the phase III DESTINY-Lung04 trial, first-line trastuzumab deruxtecan (Enhertu) gave a median progression-free survival of 14.3 months in patients with HER2-mutant advanced non-small cell lung cancer, versus 8.3 months with pembrolizumab plus chemotherapy. It is the first HER2-targeted therapy to show superiority over standard treatment in this setting.
Camizestrant plus the CDK4/6 inhibitor palbociclib missed the primary endpoint of progression-free survival compared with anastrozole plus palbociclib in the phase 3 SERENA-4 trial, AstraZeneca announced on September 11. The randomized, double-blind study enrolled 1371 patients with ER-positive, HER2-negative advanced breast cancer receiving no prior systemic therapy for advanced disease, including 194 in mainland China, across 263 sites. The result weakens the case for the oral SERD as a first-line endocrine partner to palbociclib.
Enhertu posted strong progression-free survival in the DESTINY-Lung04 trial presented at WCLC 2026: median PFS of 14.3 months, 6 months longer than control, with a 37% reduction in risk of disease progression or death and an ORR of 70% versus 44.5%. Preliminary overall survival did not favor the drug: 115 deaths (50.7%) on Enhertu versus 98 (43.2%) on control, median OS 29.3 versus 33.1 months, a 15% higher risk of death.
Ivonescimab monotherapy as first-line treatment for PD-L1-positive non-small cell lung cancer achieved a median overall survival of more than 30 months, extending survival by over 8 months compared with pembrolizumab. The phase 3 HARMONi-2 trial, led by Professor Zhou Caicun of Shanghai East Hospital and presented at the 2026 World Conference on Lung Cancer, is the first randomized double-blind phase 3 trial to show positive results for both overall survival and progression-free survival against pembrolizumab.
Two Phase III trials of B7-H3 antibody-drug conjugates in second-line relapsed small cell lung cancer, TAISHAN-302 and ARTEMIS-008, both hit their primary overall survival endpoint against topotecan, and TAISHAN-302 was published simultaneously in the New England Journal of Medicine. Reported back to back at WCLC 2026, the trials yielded identical OS hazard ratios of 0.46 (95% CI 0.35-0.62), providing independent, replicable Phase III evidence that B7-H3 ADCs beat current standard treatment in this setting.
Ivonescimab beat pembrolizumab as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC on overall survival in the registrational HARMONi-2 (AK112-303) trial, with the result reaching statistical significance. The randomised, double-blind, multicentre study was presented as a late-breaking oral at WCLC and included in the official press programme. The finding positions ivonescimab, from Akeso, as a competitor to pembrolizumab in this setting.
The B7-H3-targeted ADC Tam-Peli (YL201) improved overall survival, progression-free survival and objective response rate in patients with relapsed small cell lung cancer versus topotecan hydrochloride, according to phase III TAISHAN-302 data presented at WCLC. The drug reduced the risk of death by 54% and the risk of disease progression or death by 71%. The results position the first B7-H3 ADC to break through in second-line treatment of this disease.
Obinutuzumab outperformed tacrolimus for inducing complete remission in primary membranous nephropathy in a phase 3 trial of 142 adults. At week 104, complete remission occurred in 26 of 71 patients given obinutuzumab versus 4 of 70 given tacrolimus (37% vs. 6%; adjusted difference, 31 percentage points; P<0.001). Grade 3 or higher adverse events were similar, at 22% and 19%. The finding positions obinutuzumab as an effective alternative to tacrolimus in this disease.
AstraZeneca's oral drug camizestrant, sold as Etcamah, failed to beat standard treatment in the pivotal SERENA-4 trial as first-line therapy for ER-positive, HER2-negative advanced breast cancer. The combination did not extend the time patients went before their cancer progressed. The miss limits expansion beyond the accelerated U.S. approval for tumors with a drug-resistance mutation, though testing continues in early-stage disease.
Adding hydrogen-rich water to Ye-Shi-Shi-Lin-Formula improved outcomes in kidney stone patients in a randomized controlled trial of 100 patients treated for 12 weeks. Total effective rates were 28% in the blank group, 76% with Chinese medicine alone, 80% with hydrogen-rich water plus Chinese medicine, and 32% with hydrogen-rich water alone. The combination showed superior effects on oxidative stress, blood uric acid, urinary stone-related metabolic factors, and renal tubular function.
Why it matters: It quantifies the added benefit of hydrogen-rich water to a traditional Chinese medicine compound in a randomized trial of 100 kidney stone patients.
Fractional one-fifth and one-half doses of the 17DD yellow fever vaccine were non-inferior to the full dose in inducing initial seroconversion in children aged 9-23 months in Uganda, in a phase 4, single-blind, randomised trial. The findings support fractional-dose yellow fever vaccination of young children for outbreak response during vaccine supply shortages.
Merck and Gilead's Trodelvy failed a global phase 3 trial in first-line non-small cell lung cancer, but the China subgroup data outperformed the overall global results. FiercePharma reported that this gap could reignite debate over whether Chinese trial data can be extrapolated to Western populations.
Why it matters: A failed global phase 3 with better China subgroup results offers a direct comparison for whether Chinese trial data extrapolate to Western populations.
Definium Therapeutics' LSD formulation significantly alleviated anxiety symptoms in a third phase 3 trial, completing three straight phase 3 wins and paving the way for an FDA submission next year.
Cullinan Therapeutics and Taiho Oncology reported phase 3 data showing their therapy improved survival by more than Johnson & Johnson's Rybrevant in patients with advanced non-small cell lung cancer in the front-line setting. The comparison comes from a head-to-head context in the front-line advanced disease population.
Inhaled ARO-RAGE safely and durably silenced the RAGE target in the lung in its first human trial, published in Nature Medicine by Matthias Salathe's group at the University of Kansas Medical Center with Arrowhead. In healthy volunteers and asthma patients, soluble RAGE in serum and bronchoalveolar lavage fluid fell in a dose-dependent manner. This is the first randomized controlled trial to demonstrate safe and effective pulmonary gene silencing by an inhaled siRNA in humans, though disease benefit still requires more data.
BioNTech reported median overall survival of 18.5 months with its anti-CTLA-4 antibody gotistobart in patients with relapsed lung cancer, adding further support that the drug is better than the existing standard of care. The data were disclosed ahead of a pivotal trial readout.
GSK's risvutatug rezetecan, an antibody-drug conjugate developed with Hansoh, achieved a median overall survival of 18.5 months in a phase 3 trial. The result positions the drug as a threat to Amgen and Merck & Co. in the lung cancer field.
Teclistamab produced higher rates of complete clinical responses than lenalidomide-dexamethasone in patients with high-risk smoldering multiple myeloma in the randomized phase 2 ImmunoPRISM trial. Longer follow-up is needed to determine whether it durably prevents progression to multiple myeloma.
Intravenous glycocalyx-edited mesenchymal stem/stromal cells derived from the bone marrow of older individuals with osteoporosis proved safe and feasible in a phase 1 study of advanced osteoporosis. The cells retained clinically meaningful osteoregenerative capacity, supporting an allogeneic-style cell therapy route toward reversing bone loss rather than only slowing it.
