Next, Bristol Myers Squibb has reported interim data and a patient death from its phase 1 Breakfree-2 trial of zola-cel, a CD19-targeted CAR-T therapy, in people with multiple sclerosis. In the 66-patient study, all 60 patients at the higher dose level were off their standard MS therapies at last follow-up. Among evaluable patients with progressive MS, 92% had stable or improved disability. However, one patient with relapsing MS developed late-onset motor symptoms, later received high-dose cyclophosphamide, and died of septic pneumonia 44 days after infusion. BMS said no other treatment-related deaths have occurred across 190 patients in its zola-cel autoimmune studies.
And BioNTech and DualityBio’s HER2-targeted antibody-drug conjugate has met its phase 3 goal, but the companies say the benefit may be limited. In the DYNASTY-Breast02 trial, trastuzumab pamirtecan improved progression-free survival over chemotherapy in 541 patients with HR-positive, HER2-low metastatic breast cancer. The improvement was described as modest, and the companies did not disclose the figures. Rates of interstitial lung disease, a known risk with this class of drugs, were higher than in earlier studies. A similar drug, AstraZeneca and Daiichi Sankyo’s Enhertu, is already approved in this setting. The companies say they will discuss the data before deciding on next steps.
That’s today’s BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.
Key takeaways
- Endometrial cancer: Sac-TMT extended median overall survival to 19 months vs 12.1 months with chemotherapy in the phase 3 TroFuse-005 trial.
- CAR-T in MS: Early zola-cel data showed patients off standard therapies, but one patient died of septic pneumonia after treatment.
- Limited benefit: Trastuzumab pamirtecan met its phase 3 PFS goal, but an approved competitor narrows its potential role in HER2-low breast cancer.
