Bristol Myers Squibb announces success of KRAZATI in Phase 3 KRYSTAL-12 study

Bristol Myers Squibb (NYSE: BMY) has reached a pivotal milestone in the treatment of non-small cell lung cancer (NSCLC) with its announcement regarding the KRYSTAL-12 study’s success. The study focused on evaluating KRAZATI (adagrasib) as a monotherapy for patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation. KRAZATI met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR), as assessed by a Blinded Independent Central Review (BICR).

This landmark study remains ongoing to assess the additional key secondary endpoint of overall survival. The confirmatory trial results demonstrate that KRAZATI significantly benefits PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment. Importantly, KRAZATI exhibited no new safety signals, with data consistent with its known safety profile.

Abderrahim Oukessou, M.D., vice president and global program lead for KRAZATI at Bristol Myers Squibb, expressed optimism about the results: “Today’s news is an important reinforcement of the power of a targeted therapy for patients with locally advanced or metastatic KRASG12C-mutated lung cancer. FDA approval of KRAZATI in the U.S. has allowed us to provide a new treatment option for these patients, and topline results of the KRYSTAL-12 confirmatory study will build greater trust in the medical and patient community.”

Bristol Myers Squibb’s KRAZATI Shows Promise in Phase 3 Study for NSCLC

The company is preparing a comprehensive evaluation of the available data and plans to share these findings with the scientific community at an upcoming medical conference, in addition to discussions with health authorities.

KRAZATI’s journey includes accelerated approval by the U.S. FDA in December 2022 for patients with KRASG12C-mutated locally advanced or metastatic NSCLC, followed by approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) for similar indications. Besides NSCLC, KRAZATI and its combinations have shown potential benefits in Phase 2 clinical trials for various tumors, including colorectal and pancreatic cancers.

The U.S. FDA has also accepted a supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for KRASG12C-mutated colorectal cancer, with a Prescription Drug User Fee Act (PDUFA) goal date set for June 21, 2024.

Bristol Myers Squibb extends its gratitude to the patients and investigators involved in the KRYSTAL-12 clinical trial for their pivotal role in advancing cancer treatment.

The KRYSTAL-12 study’s positive results underscore the significant strides being made in targeted therapy for NSCLC, particularly for those with the KRASG12C mutation. KRAZATI’s success in meeting its primary and secondary endpoints highlights the potential of targeted treatments to provide meaningful benefits over traditional chemotherapy, with the added advantage of a consistent safety profile. This development represents a hopeful advance in the fight against lung cancer, offering new treatment avenues for patients with advanced stages of this challenging disease.