Lilly's phase 3 miss dents Verzenio prospects in hot lung cancer field

Eli Lilly headquarters
Eli Lilly's Verzenio won its first FDA approval last month.

Eli Lilly’s Verzenio needs to stand out in a new class of cancer meds, and the company was hoping success in lung cancer patients with a particular mutation could be just the ticket. But its ambitions in that department have now taken a hit.

Lilly had bet that the CDK 4/6 inhibitor, now competing with Pfizer's heavyweight Ibrance, could chalk up success in KRAS-mutated non-small cell lung cancer, opening up a big new market. But on Tuesday, the company said Verzenio (abemaciclib) missed its endpoint in a phase 3 study, failing to significantly beat out Roche’s Tarceva at extending overall survival in patients who had already undergone platinum-based chemo.

Lilly was quick to point to some qualifiers in the data in an attempt to soften the blow. The news isn't all bad, the company said; for one thing, the Tarceva arm in the study came through with a higher-than-expected overall survival rate, raising the bar for Verzenio to clear. And Lilly’s drug did show evidence of results in progression-free survival and overall response rate, though the company couldn’t say how much. More answers will come during a presentation at a medical meeting next year, it said.

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Meanwhile, it’s safe to say the outcome of the closely watched trial, dubbed Juniper, isn’t what Lilly was hoping for as it goes up against entrenched in-class giant Ibrance. Verzenio, which nabbed its FDA green light in HR-positive, HER2-negative breast cancer late last month, represents the third-to-market rival behind Ibrance and Novartis’ Kisqali, and as Credit Suisse analyst Vamil Divan, M.D., recently noted, thanks to Ibrance’s “strong foothold” in the market, Kisqali has faced “challenges … in gaining traction.”

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With that in mind, Divan recently tweaked his assumptions for the Lilly medication, assuming sales of about $500 million by 2020, with an increase to about $1.7 billion by 2025. “Success in the non-small cell lung cancer indication through the Juniper study would be an important positive differentiating factor,” he wrote to clients on Monday night before results dropped.

Lilly, though, isn’t planning on quitting in non-small cell lung cancer. "As we analyze secondary endpoints and explore specific patient subgroups in order to better evaluate the prospects for abemaciclib in NSCLC, we will continue to work with the oncology community to inform potential future treatment avenues for patients with KRAS-mutated advanced lung cancer,” Levi Garraway, M.D., Ph.D., Lilly Oncology’s SVP of global development and medical affairs, said in a statement. The company has “several” ongoing studies looking at Verzenio combos in non-small cell lung cancer and elsewhere, he added.