Zai Lab Limited, in collaboration with Bristol Myers Squibb, announced significant progress in the fight against lung cancer with the successful outcome of the KRYSTAL-12 study for KRAZATI® (adagrasib), specifically targeting NSCLC with KRASG12C mutations. The Phase 3 study achieved its primary endpoint, progression-free survival (PFS), and a key secondary endpoint, overall response rate (ORR), highlighting the therapy’s potential as a significant advancement for patients with locally advanced or metastatic NSCLC who have received prior treatments. The results reflect a meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy for second-line or later treatment, without new safety concerns.
Rafael G. Amado, M.D., President and Head of Global Oncology Research and Development at Zai Lab, expressed enthusiasm about adagrasib’s potential and its particularly critical role in addressing China’s lung cancer burden, the most common cancer in the country. The company plans to submit an NDA for adagrasib in China for second or later line treatment of KRASG12C mutated NSCLC within the year, aiming to expand treatment options for patients.
The KRAZATI and related combinations have also shown promising results in Phase 2 clinical trials for additional tumors like advanced colorectal and pancreatic cancer. The U.S. FDA’s priority review of KRAZATI in combination with cetuximab for metastatic colorectal cancer (CRC) emphasizes the broad potential of this therapy.
With lung cancer resulting in significant morbidity and mortality in China, advancements like KRAZATI represent crucial steps forward in oncologic care, offering new hope to patients and potentially shaping future treatment landscapes.
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.
