MSD’s Keytruda has been awarded full approval in the US in combination with Lilly’s Alimta and platinum chemotherapy as first-line treatment for metastatic non-squamous non-small cell lung cancer.
The expanded approval allows physicians to treat patients who do not carry any EGFR or ALK mutations.
The decision rides on the back of data from the Phase III KEYNOTE-189 trial, which showed that, regardless of PD-L1 tumor expression status, the combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by half compared to chemotherapy alone.
Keytruda (pembrolizumab) in combination with Alimta (pemetrexed) and carboplatin was first approved in 2017 under the FDA’s accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and progression-free survival data from the Phase II KEYNOTE-021 study.
Continued approval was contingent upon verification and description of clinical benefit the drug’s clinical benefit in this setting, which has now been demonstrated in KEYNOTE-189, the firm noted.