FDA approves tepotinib for metastatic NSCLC with MET exon 14 skipping alterations

“The primary efficacy measures were ORR and DOR, determined by a Blinded Independent Review Committee. Among 164 treatment-naïve patients, ORR was 57% (95% CI: 49, 65), with 40% of responders having a DOR ≥12 months. Among 149 previously treated patients, ORR was 45% (95% CI: 37, 53), with 36% of responders having a DOR ≥12 months. The most common adverse reactions (≥20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.”

Share:

More News

Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit

“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade

“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and

“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month