Eli Lilly turned in a surprising but potentially complicated "win" for its Phase III trial of necitumumab, its successor to the blockbuster Erbitux which looked all but dead a few months ago. The pharma giant ($LLY) says that the late-stage study produced promising overall survival data for non-small cell lung cancer, setting up a key regulatory filing in 2014.
Lilly isn't releasing any data today, but investigators reported that the drug--obtained in the Imclone buyout--met its primary endpoint, finding that patients with stage IV metastatic squamous non-small cell lung cancer experienced significantly increased overall survival times when taking the drug in combination with gemcitabine and cisplatin as a first-line treatment, as compared to chemotherapy alone.
"This is a clear upside surprise, as consensus (and my) expectations for this drug were basically zero," responded ISI's Mark Schoenebaum after looking over the release. Investors agreed, sending Lilly shares up 4.5% after the news hit.
Doubts about necitumumab grew near the beginning of the year after Bristol-Myers Squibb ($BMY) walked away from its development partnership with Eli Lilly, won only after a bitter legal dispute over the rights to the drug. That move came more than a year after investigators were forced to stop enrolling patients in one of their Phase III trials after monitors detected a risk of blood clots among new and recently enrolled subjects.
Those safety fears are likely to trail Lilly into the regulatory process. Researchers said they tracked instances of rash and hypomagnesemia among patients. Added Lilly: "Serious, but less frequent, adverse events occurring more often on the necitumumab arm included thromboembolism."
Schoenebaum noted that the drug could earn peak sales of $1.5 billion a year following an approval, making this a potential blockbuster for Lilly, which desperately needs to replace drugs facing generic competition.
Biotech aficionados might recall that necitumumab was initially dubbed IMC-11F8, a fully human antibody and next-gen version of Erbitux, an animal/human hybrid which also targets EGFR. Researchers felt that its fully human attributes would make it safer and more effective in combating tumors with fewer doses required. BMS, which started the bidding war for ImClone that Eli Lilly eventually won for $6.5 billion, secured part of the rights for the drug after the buyout.
"If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer," Richard Gaynor, Lilly's vice president for product development and medical affairs, said in a statement.
Most analysts tracking Eli Lilly's oncology work have been focusing on the stomach cancer drug ramucirumab, the subject of six Phase III studies. Earlier this year researchers spelled out some early Phase III results, with data demonstrating a median overall survival time of 5.2 months compared to the 3.8 months seen in a control arm. As Lilly noted, the data met its interpretation for statistical significance, but analysts were looking for at least a two-month spread in the data to highlight efficacy.
- here's the press release