Bristol Myers Squibb has announced significant outcomes from its Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) in patients with pretreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation. This pivotal trial met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR), marking a pivotal advancement in targeted cancer therapy.
The KRYSTAL-12 trial’s success strengthens the position of KRAZATI as a monotherapy offering considerable benefits in PFS and ORR compared to standard-of-care chemotherapy, specifically for patients undergoing their second-line or later treatment. This is especially significant for those with the KRASG12C mutation in NSCLC, a demographic previously underserved by targeted cancer therapies. KRAZATI was well tolerated among patients, with safety data aligning with its known safety profile and no new safety signals observed.
The FDA’s accelerated approval of KRAZATI in December 2022 represented a groundbreaking shift in treatment paradigms for patients with KRASG12C-mutated NSCLC. This was further reinforced internationally with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) granting conditional marketing authorization in 2023 and 2024, respectively.
Beyond NSCLC, KRAZATI and KRAZATI-based combination therapies have demonstrated promising outcomes in Phase 2 clinical trials for various solid tumors, including advanced colorectal cancer, pancreatic cancer, and other malignancies. Particularly noteworthy is the supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for colorectal cancer patients with the KRASG12C mutation, which the U.S. FDA accepted for priority review with a Prescription Drug User Fee Act (PDUFA) goal date set for June 21, 2024.
Bristol Myers Squibb has expressed gratitude to patients and investigators involved in the KRYSTAL-12 trial and anticipates sharing detailed results with the scientific community at an upcoming medical conference. This exciting development underscores the company’s commitment to pioneering targeted therapies that offer hope to patients facing advanced and metastatic cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
