RE:RE:Sanofi Exploring Acquisition of KRAS Cancer Drugmaker MiratiMirati was previously rumored to be an M&A target among Big Pharma companies. But early combination data for its KRAS inhibitor Krazati and Merck’s PD-1 inhibitor Keytruda in KRAS-mutated non-small cell lung cancer disappointed investors and called into question Krazati’s overall market potential.
Then in August, Mirati finally confirmed plans to run a phase 3 trial for the Krazati-Keytruda combination in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) who have high levels of PD-L1 expression. This is by itself is a blockbuster market, according to Mirati.
Meanwhile, Bloomberg’s report came on the same day Mirati’s KRAS rival Amgen went before an FDA advisory committee of external experts to defend its own drug, Lumakras.
The Amgen drug previously showed a benefit in delaying disease progression or death compared with chemotherapy in a confirmatory trial in KRAS G12C-mutated NSCLC. But an FDA internal review flagged several problems of “systemic bias” with the study.
After the discussion, panelists voted 10-2 that they cannot properly interpret the primary endpoint in Amgen’s late-stage study, dubbed CodeBreak 200.
Still, the agency said it doesn't plan to force the drug off the market right now.
Krazati currently holds an edge over Lumakras in the next phase of KRAS battle. Serious liver toxicity has forced Amgen to essentially abandon a Lumarkas combination with Keytruda, while the side effect appears manageable for Krazati.
Sanofi's rumored interest follows a flurry of M&A activity for the French drugmaker. Late last year, the company started—but eventually lost—the bidding war for rare disease specialist Horizon Therapeutics.
Then, in March, Sanofi laid down $2.9 billion for its diabetes partner Provention Bio, the marketer of Type 1 diabetes therapy Tzield.
More recently, Bloomberg reported the company was involved in talks to buy Reata Pharmaceuticals, which eventually sold to Biogen.
Before those deals and deliberations, Sanofi bought Ablynx for 3.9 billion euros in 2018, and it purchased Principia Biopharma for $3.7 billion in 2020.
https://www.fiercepharma.com/pharma/sanofi-weighs-mirati-buy-kras-cancer-drug-battle-enters-new-phase-bloomberg