Five Prime Therapeutics' pancreatic cancer combo with Opdivo a bust

outside of building
Bristol-Myers “has no near-term plans for additional sponsored development of cabiralizumab.” (Bristol-Myers Squibb)

Wedding Five Prime Therapeutics’ experimental CSF-1 receptor inhibitor cabiralizumab to Bristol-Myers Squibb’s checkpoint inhibitor Opdivo has proved a bust in pancreatic cancer.

It’s not much of a surprise in terms of a cancer target: Pancreatic cancer has one of the lowest success rates in recent times amid biopharma oncology trials and is often diagnosed late in the disease, with a very high level of mortality.

In a brief update with few details, Five Prime and Bristol-Myers said the midstage test of cabiralizumab with Opdivo (nivolumab), and either with or without chemo in patients with advanced pancreatic cancer, “did not meet its primary endpoint.”

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The biotech added that Bristol-Myers “has no near-term plans for additional sponsored development of cabiralizumab,” but will “continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset.”

“Pancreatic cancer is a difficult disease to treat, and unfortunately the combination of cabiralizumab and Opdivo with and without chemotherapy did not show any meaningful benefit over standard of care chemotherapy in this randomized, controlled phase 2 trial,” said Helen Collins, M.D., executive VP and CMO of Five Prime. “We are disappointed by this outcome and appreciate the participation of the investigators, staff, patients, caregivers, and our development partner who all contributed to the conduct and completion of this Phase 2 clinical trial.”

This heaps yet more woe upon the biotech after a pretty miserable 18 months: In the fall of last year, and coming less than two years after taking the reins from founding chief Rusty Williams, Five Prime CEO Aron Knickerbocker quit the company.

That came around nine months after he swung the ax across the biotech, cutting 20% of its workforce and its early-stage R&D in order to focus on its clinical cancer programs.

He was replaced in the interim by Chairman Bill Ringo, who a month later moved to lay off 70 employees. The cuts left Five Prime with a “small research group” focused on taking clinical candidates forward with the help of service providers and contractors.

As COO, it was in fact Knickerbocker who orchestrated the $1.74 billion partnership with Bristol-Myers that paired the biotech’s I-O candidate cabiralizumab with Opdivo.

The company is also working on a phase 3 combo test with another of its experimental medicines in the form of bemarituzumab, a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity. The drug is partnered with Chinese company Zai Lab.

The cabiralizumab combo flop follows similar trial failures in pancreatic disease for a host of companies, including Eli Lilly/Armo, NuCana, GlaxoSmithKline and Halozyme, although there has been a recent positive out of Chi-Med this year. 

Shares in the biotech fell around 10% on the initial news.

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