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BMS’ Opdivo combo misses the mark in pancreatic cancer

Failed to reach primary endpoint of progression-free survial


A combination of Bristol-Myers Squibb’s Opdivo and Five Prime Therapeutics’ cabiralizumab failed to demonstrate efficacy in advanced pancreatic cancer. 

The Opdivo (nivolumab) combination was being studied in a phase 2 trial, with and without chemotherapy, but failed to reach the primary endpoint of progression-free survival up to 12 months.

The patient population included 160 people with locally advanced or metastatic pancreatic cancer that had progressed during or after one line of chemotherapy.

Patients were randomised to receive the Opdivo/cabiralizumab combination, chemotherapy alone, or the Opdivo/cabiralizumab with one of two different chemotherapy regimens.

According to Five Prime, the combination did not show any significant benefit over chemotherapy treatment, in terms of the PFS rate.

The blow is more significant for Five Prime than it is for BMS – the cabiralizumab plus Opdivo programme in pancreatic cancer is one of its more advanced pipeline projects.

There is consolidation in the fact that pancreatic cancer is notoriously hard-to-target, with scores of drug developers failing in this area. It also carries poor survival rates – less than 7% of patients are still alive five years after a pancreatic cancer diagnosis.

The California, US-based biotech said that BMS has “no near term plans for additional sponsored development of cabiralizumab”, but that it will continue to support research of the drug in specific ongoing investigator-sponsored trials.

BMS could also reportedly continue to assess future development opportunities for cabiralizumab. Five Prime’s drug is an CSF1R-targeting antibody, and has been shown in preclinical models and clinical studies to block the activation and survival of monocytes and macrophages.

It works to reduce the number of immunosuppressive tumour-associated macrophages, which in turn kick-starts an immune response against tumours.

“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 randomised, controlled phase a trial,” said Helen Collins, executive vice president and chief medical officer of Five Prime Therapeutics.

“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,” she added.

Despite a number of fails in the area, some advancements have been made in treatments for pancreatic cancer, such as Astrazeneca and Merck’s PARP inhibitor Lynparza (olaparib).

The partners won approval for Lynparza in January as a first-line maintenance therapy for metastatic pancreatic cancer patients who have BRCA mutations.

Around 5-6% of pancreatic cancers are caused by mutation in one or both BRCA genes, which are more commonly associated with ovarian and breast cancers.

Article by
Lucy Parsons

19th February 2020

From: Research



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