HRS-7535, Hengrui Pharma's oral small-molecule GLP-1 receptor agonist, met non-inferiority versus dapagliflozin in the China phase 3 OUTSTAND-2 trial in type 2 diabetes patients inadequately controlled on metformin. HbA1c fell 1.50% to 1.68% across the 30 mg, 60 mg and 90 mg doses, versus 1.28% with dapagliflozin; the 90 mg dose was superior. Full methods are set for publication in Nature Medicine.
Firmonertinib missed the primary endpoint of progression-free survival assessed by blinded independent central review in the global phase 3 FURVENT trial as first-line therapy for EGFR exon 20 insertion-mutated non-small cell lung cancer. The three-arm open-label study enrolled 398 untreated patients with locally advanced or metastatic non-squamous NSCLC, comparing once-daily 160mg and 240mg doses against pemetrexed plus platinum chemotherapy. The 240mg arm showed median PFS of 11.0 months versus 9.5 months for chemotherapy, HR 0.75 (95% CI 0.55-1.02), p=0.0654, short of the prespecified significance level.
Adding AbbVie and Genmab's Epkinly to R-CHOP cut the risk of disease progression or death by 51% in newly diagnosed diffuse large B cell lymphoma, hitting the primary endpoint of the 900-patient Phase 3 EPCORE DLBCL-2 trial. The benefit exceeded analyst expectations of 30-35%, was consistent across high-risk and low- to intermediate-risk disease, and beats the 27% and 25% reductions reported for Polivy and Monjuvi regimens, positioning Epkinly as a potential first-line standard of care.
The final survival analysis of the MAIA study, published in Leukemia, shows daratumumab plus lenalidomide and dexamethasone (D-Rd) extends median overall survival by 26.2 months over lenalidomide plus dexamethasone (Rd) in transplant-ineligible newly diagnosed multiple myeloma. With median follow-up of 89.3 months in 737 patients, median OS was 90.3 months with D-Rd versus 64.1 months with Rd, and 7-year OS rates were 53.1% versus 39.3%. The results establish OS, not just progression delay, as a reason to choose D-Rd first-line in this population.
Final MATTERHORN data show that perioperative durvalumab plus FLOT, previously shown to significantly improve event-free survival over FLOT alone in gastroesophageal cancer, also converts that benefit into an overall survival benefit. The Chinese ASTRUM-006 trial separately validates perioperative serplulimab plus SOX in PD-L1-positive disease, establishing perioperative immunochemotherapy globally.
The phase 3 TAISHAN-302 trial tested the anti-B7-H3 antibody-drug conjugate econtambetamab tazepibody (Tam-Peli, YL201) against topotecan in patients with recurrent small cell lung cancer. Professor Zhang Li of Sun Yat-sen University Cancer Center presented the efficacy and safety results in a plenary session at the 2026 World Conference on Lung Cancer in Seoul on September 13, 2026, with simultaneous publication in the New England Journal of Medicine. The data position this ADC against standard topotecan in recurrent SCLC.
Weekly subcutaneous obexelimab, 250 mg for 52 weeks, cut the risk of IgG4-related disease flare requiring rescue therapy by more than half in a phase 3 trial of 194 patients (hazard ratio 0.44; flares in 26.8% vs. 54.6% with placebo). Complete remission at week 52 was reached by 37.1% versus 19.6%, and cumulative glucocorticoid rescue dose was 329.5 mg versus 929.8 mg. The results position this non-depleting anti-CD19/FcγRIIb antibody as an alternative to glucocorticoid-dependent management.
Vaxcyte reported positive topline results from the pivotal late-stage OPUS-1 trial of VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. The company's shares rose more than 50% premarket, touching 86 dollars per share, with analysts raising target prices to 90 to 100 dollars. VAX-31 aims to compete in an 8 billion dollar adult pneumococcal conjugate vaccine market now dominated by Pfizer's Prevnar 20 and Merck's Capvaxive through broader serotype coverage.
Why it matters: Positive pivotal OPUS-1 topline data for VAX-31 position a 31-valent vaccine against the two products now dominating the adult pneumococcal vaccine market.
Kodiak Sciences announced topline data from the late-stage DAYBREAK trial, in which both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) met the primary endpoints in wet age-related macular degeneration (wAMD). The company's shares surged 178% overnight after the announcement.
Litifilimab cleared or almost cleared skin in 27.2% of cutaneous lupus erythematosus patients at one year in the Phase 2a AMETHYST trial, up from 19% at week 24, with 28.8% achieving at least 70% reduction in disease severity. The study covered 93 adults who had not responded to or could not tolerate antimalarials, and safety showed no new signals. The durable responses strengthen the case for litifilimab ahead of Phase 3 CLE data expected in 1H27 and SLE readouts in Q4, in a disease with no approved drugs.
Once-daily oral safiglipron, a small-molecule GLP-1RA, was non-inferior to dapagliflozin for HbA1c reduction at all tested doses and superior at 90 mg in adults with type 2 diabetes in a randomized, double-blind, active-comparator-controlled phase 3 trial. Safiglipron gave greater improvements in glycemic control, similar modest weight loss, and an acceptable safety profile. It offers an oral alternative in the GLP-1 receptor agonist class.
Weekly cisplatin at 40 mg/m2 with 70 Gy radiation did not reduce serious acute toxicity versus 100 mg/m2 every three weeks in 234 patients with p16-negative locally advanced head and neck squamous cell carcinoma in the phase II NRG-HN009 trial. The mean T-score ratio was 1.11 (p=0.77), with T-scores of 2.23 versus 2.48, and six-month locoregional failure was 4.6% versus 9.6%. The cohort did not advance to phase III, leaving the every-three-week schedule unchallenged on toxicity grounds.
Long-term data presented at the 35th EADV congress in Vienna show that most adolescents with moderate-to-severe atopic dermatitis achieved an EASI-75 response at week 54 of treatment with the drug branded in China as Simuqibai. The findings, released at the European Academy of Dermatology and Venereology annual meeting, address the need for safe and effective long-term therapy in this age group.
Retatrutide delivered an average weight loss of 20.8% at 80 weeks in the 12 mg group of the TRIUMPH-2 trial, which enrolled 1152 people with T2D across dose arms. A subgroup with baseline BMI of 35 or higher lost 23.4%. The topline results were published in The Lancet, and Eli Lilly plans to file with the FDA in Q1 2027.
Eli Lilly has released detailed results from ACHIEVE-4, the phase 3 trial of the oral GLP-1 receptor agonist orforglipron. Diabetes is now the third most serious chronic disease threatening human health after cancer and cardiovascular and cerebrovascular disease. China has more than 140 million people with type 2 diabetes, and clinical care has shifted to integrated management of blood glucose, blood lipids, and cardiovascular risk.
A prospective, single-arm phase II feasibility study enrolled five patients with NSCLC to assess the safety and feasibility of at-home subcutaneous atezolizumab (1,875 mg every 21 days). Of 70 treatment cycles, 65 injections (93%) were delivered on time. Home administration took a mean of 42.3 minutes versus 86.7 minutes in clinic. Two of five patients (40%) had adverse events, and mean patient satisfaction with administration was 3.3/4.
In severe aortic stenosis with coronary artery disease, performing TAVI before PCI was noninferior to PCI first for the one-year primary composite endpoint after randomization, the randomized TAVI PCI trial in NEJM shows; superiority was not established. All-cause death was 9.5% in both groups, and the TAVI-first group had lower rates of BARC type 3a bleeding. The trial, run across 29 high-volume German heart valve centers, is the first randomized comparison of the two staging orders when both procedures are planned.
CBL-514, an injectable that selectively induces apoptosis of fat cells, cut abdominal visceral adipose tissue volume by 12.01% from baseline four weeks after the last treatment in phase 2 participants (n=23), while placebo recipients (n=17) gained 5.68%, a 17.69 percentage-point difference. At later follow-up the between-group difference was 22.21 percentage points, and the drug was generally well tolerated with mostly mild injection-site reactions. Phase 3 trials for nonsurgical abdominal fat reduction are now recruiting.
Why it matters: Phase 2 MRI data show an injectable fat-cell apoptosis drug reduces visceral fat, a target current obesity drugs do not directly address.
A phase 3 randomized controlled trial of safiglipron (HRS-7535), an oral small-molecule GLP-1 receptor agonist developed by Hengrui Pharma for early type 2 diabetes, was completed by the team of Xiao Xinhua and Ye Zi and published in Nature Medicine. Safiglipron is taken once daily by mouth, requires no injection, and has no fasting or food and water intake restrictions before or after dosing, potentially simplifying current GLP-1 receptor agonist treatment. The study evaluated its efficacy, safety, and metabolic effects as monotherapy.
