Ph 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of OS and PFS in Certain Patients With 1L Locally Advanced or Metastatic Urothelial Cancer
“The results of this pivotal Phase 3 study are highly encouraging and showed a statistically significant survival benefit for the combination of KEYTRUDA with the antibody-drug conjugate enfortumab vedotin in cisplatin-eligible or cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This is an important milestone, as many patients with advanced urothelial carcinoma still experience disease progression following chemotherapy. We look forward to sharing these data with the medical community and regulatory authorities.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000