Krazati slows disease progression in certain patients with lung cancer
Click Here to Manage Email Alerts
Adagrasib monotherapy improved PFS and overall response rate among adults with pretreated locally advanced or metastatic non-small cell lung cancer harboring a KRASG12C-mutation, according to results from a confirmatory phase 3 trial.
Adagrasib (Krazati, Bristol Myers Squibb) —an RAS GTPase inhibitor — received accelerated approval from the FDA for the treatment of adults with KRASG12C -mutated locally advanced or metastatic NSCLC who received at least one previous systemic therapy. The randomized phase 3 KRYSTAL-12 trial evaluated adagrasib compared with standard-of-care chemotherapy as second-line therapy or later for adults with advanced or metastatic KRASG12C-mutated disease.
An analysis determined the agent met the study’s primary endpoint of PFS and the key secondary endpoint of ORR. Second-line or later treatment with adagrasib resulted in “statistically significant and clinically meaningful” improvement of both study endpoints compared with standard therapy, according to a press release from the manufacturer.
“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,” Abderrahim Oukessou, MD, vice president and global program lead for Krazati at Bristol Myers Squibb, said in the release.
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,” he added. “We are encouraged by the results from KRYSTAL-12 and look forward to helping more patients with KRASG12C-mutated lung cancer.”
The KRYSTAL-12 study remains active to assess other secondary endpoints, including data on OS. Investigators from the multicenter trial reported saftey data remained consistent with adagrasib’s established saftey profile, with no new safety signals during the study.
Data from the open-label trial will be shared with regulatory authorities and presented at an upcoming medical conference, according to the manufacturer’s release.
Read more about
Click Here to Manage Email Alerts