1. Positive Phase 3 Results for LP.8.1-Adapted COMIRNATY® has been Reported
On September 8, 2025, Pfizer and BioNTech announced positive results from an ongoing Phase 3 clinical trial evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. Data showed an increase in the neutralising antibody level targeting the LP.8.1 sublineage of SARS-CoV-2 after vaccination. These new clinical findings reinforce the recent U.S. FDA approval of the LP.8.1-adapted COVID-19 vaccine.
2. Pumitamig Plus Chemotherapy Achieves 76.3% Response Rate in Phase 2 ES-SCLC Trial
On September 8, 2025, BMS and BioNTech announced data from a global randomised Phase 2 trial evaluating pumitamig, an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). The 43 patients with pumitamig plus chemotherapy showed a confirmed overall response rate of 76.3% (85.0% at 20 mg/kg and 66.7% at 30 mg/kg) and a disease control rate of 100%. Moreover, patients experienced a mean tumor shrinkage of 56.7%, with 89.5% achieving early tumor shrinkage. The median progression-free survival was 6.8 months, while the overall survival data were not mature yet.
3. FDA Approves INLEXZO™ for BCG-Unresponsive or Surgery-ineligible Bladder Cancer
On September 9, 2025, J&J announced that the U.S. FDA had approved INLEXZO™ (gemcitabine intravesical system), a new approach to treat patients with bladder cancer. The new system addresses the need for patients with unsuccessful BCG therapy and for patients who refuse or are ineligible for bladder removal surgery. The system can slowly release gemcitabine in the bladder over an extended period. The FDA approval is based on the Phase 2b SunRISe-1 trial, which showed an 82% complete response rate in patients with BCG-unresponsive NMIBC, with 51% maintaining response for at least one year.
4. Jaypirca Significantly Prolongs Progression-Free Survival in Phase 3 BRUIN CLL-313 Trial
On September 8, 2025, Eli Lilly and Company reported that the Phase 3 BRUIN CLL-313 trial showed Jaypirca (pirtobrutinib) significantly improved progression-free survival versus chemoimmunotherapy (bendamustine + rituximab) in treatment-naïve CLL/SLL patients without 17p deletions. Till now, theverall survival results were not yet mature but favored pirtobrutinib. The safety profile was consistent with earlier studies. This is the third positive Phase 3 study from the pirtobrutinib development program.
5. Rocatinlimab Demonstrates Long-Term Safety and Sustained Efficacy
On September 8, 2025, Amgen and Kyowa Kirin announced topline results from the ASCEND study of rocatinlimab, an investigational OX40-targeting T-cell rebalancing therapy, in moderate to severe atopic dermatitis. The primary safety analysis showed that the most frequent adverse events were upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis, consistent with earlier findings, while discontinuation due to adverse events was low, and gastrointestinal ulceration incidence remained rare. For patients who had previously achieved a response, most maintained clinical benefit at one year on continued monotherapy, with sustained improvements in skin clearance, itch, disease extent, and severity. The study remains ongoing to assess long-term safety and efficacy over 104 weeks in both adults and adolescents.
6. Libtayo Plus Chemotherapy Shows Significant Five-Year Survival Benefit for Advanced NSCLC
On September 9, 2025, Regeneron announced five-year follow-up results from the Phase 3 EMPOWER-Lung 3 trial, showing that Libtayo® (cemiplimab) plus chemotherapy continued to show significant survival benefits versus chemotherapy alone in first-line advanced NSCLC patients without EGFR, ALK, or ROS1 alterations.
With a median follow-up of 60.9 months, the combination therapy achieved a median overall survival of 21.1 months versus 12.9 months, reducing the risk of death by 34% and yielding a five-year survival probability of 19.4% compared with 8.8% for chemotherapy alone. Median progression-free survival was 8.2 months versus 5.5 months, the objective response rate was 43.6% versus 22.1%, and median duration of response was 16.4 months versus 7.3 months. Subgroup analyses confirmed consistent benefits across histologies and PD-L1 expression, including a 22.3-month median OS in squamous NSCLC, 19.4 months in non-squamous NSCLC, and 24.0 months in patients with PD-L1 ≥1%.
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