SHANGHAI & CAMBRIDGE, Mass. - Zai Lab (NASDAQ:ZLAB) Limited (NASDAQ: ZLAB; HKEX: 9688) and its partner Bristol Myers Squibb (NYSE: NYSE:BMY) announced that the Phase 3 KRYSTAL-12 study of KRAZATI (adagrasib) met its primary endpoint of progression-free survival (PFS) in patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC).
The trial, which also achieved the key secondary endpoint of overall response rate (ORR), evaluated the efficacy of adagrasib as a second-line or later treatment compared to standard chemotherapy.
The results, deemed statistically significant and clinically meaningful, showed that adagrasib improved PFS and ORR without introducing new safety concerns. These findings are consistent with adagrasib's known safety profile. The study will continue to assess overall survival as an additional key secondary endpoint.
Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab, expressed optimism about adagrasib's potential as a therapy for NSCLC patients in China, where lung cancer is the most prevalent cancer. Zai Lab plans to submit a New Drug Application (NDA) for adagrasib to China's National Medical Products Association (NMPA) within the year.
Adagrasib has already received accelerated approval by the U.S. FDA for treating KRASG12C-mutated NSCLC in patients who have undergone at least one prior systemic therapy. This approval is contingent upon outcomes from confirmatory trials. The European Commission followed the Medicines and Healthcare products Regulatory Agency (MHRA) in granting conditional marketing authorization for adagrasib in a similar patient population.
Beyond NSCLC, adagrasib and its combinations are showing promise in Phase 2 trials against other solid tumors, including colorectal and pancreatic cancers. The FDA has accepted a supplemental new drug application (sNDA) for adagrasib in combination with cetuximab for treating KRASG12C-mutated colorectal cancer, with a decision expected by June 21, 2024.
The KRYSTAL-12 trial is part of an ongoing effort to evaluate adagrasib as both a monotherapy and in combination with other treatments for advanced solid tumors. Zai Lab, which focuses on oncology, autoimmune, infectious diseases, and neuroscience, aims to leverage its research to address unmet medical needs globally.
This article is based on a press release statement.
InvestingPro Insights
Zai Lab Limited's recent success with the KRYSTAL-12 study is a significant milestone in its pursuit of advanced treatments for non-small cell lung cancer. As investors and stakeholders consider the implications of this development, a glance at Zai Lab's financial health and market performance provides additional context. With a market capitalization of $1.58 billion, Zai Lab is a considerable player in the biopharmaceutical space. Despite challenges, the company holds more cash than debt on its balance sheet, an InvestingPro Tip that suggests a level of financial resilience.
Another InvestingPro Tip highlights that analysts expect sales growth for the current year, indicating confidence in Zai Lab's revenue-generating capabilities. This optimism is reflected in the company's revenue growth, which was reported at 24.03% for the last twelve months as of Q4 2023. Nevertheless, Zai Lab has faced difficulties, with a negative gross profit margin of -35.6% over the same period, which points to cost management challenges.
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