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Press Release

October 28, 2021
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Devimistat regimen fails to extend OS in metastatic pancreatic cancer

Source:

Press Release

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Devimistat plus a modified standard-of-care chemotherapy regimen failed to extend OS among patients with metastatic pancreatic cancer, according to results of the randomized phase 3 AVENGER 500 trial released by the agent’s manufacturer.

Devimistat (CPI-613, Rafael Pharmaceuticals) is designed to selectively target the mitochondrial tricarboxylic acid cycle in the mitochondria of cancer cells. This process is essential to tumor cell multiplication and survival.

The agent received FDA fast track designation last November for treatment of pancreatic cancer and in December for treatment of acute myeloid leukemia.

“These cancers are incredibly difficult to treat, with few to no effective treatments available, but Rafael took the risk because we will always fight for our patients,” Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, said in a company-issued press release. “While we are disappointed by the outcomes of these well-designed and well-executed studies, we remain committed to furthering our research and development in cancer metabolism for the treatment of hard-to-treat cancers, as our other studies continue.”

The multinational AVENGER 500 trial included 528 patients with previously untreated metastatic adenocarcinoma of the pancreas. Researchers randomly assigned patients to receive either devimistat plus modified FOLFIRINOX or standard-of-care FOLFIRINOX chemotherapy. Results showed the devimistat combination did not significantly extend OS (HR = 0.95). Median OS was 11.1 months in the devimistat group and 11.7 months in the FOLFIRINOX group.

Philip A. Philip, MD, PhD, FRCP
Philip A. Philip

“Pancreatic cancer carries a high mortality rate and is extremely difficult to treat, but promising earlier clinical data encouraged us to move into this advanced phase trial with devimistat,” Philip A. Philip, MD, PhD, FRCP, principal investigator and medical oncologist at Karmanos Cancer Institute at Wayne State University, said in the press release. “While these are not the results we all hoped for, we will not give up, and we are hopeful that devimistat with its novel mechanism of action will demonstrate efficacy in other studies.”

Devimistat also was being evaluated among patients with relapsed or refractory AML in the phase 3 ARMADA 2000 trial. An independent data monitoring committee has recommended that trial be halted due to lack of efficacy following a prespecified interim analysis.

Jorge Cortes, MD
Jorge Cortes

“Earlier clinical trial data demonstrated positive results, despite the challenges we face in treating AML,” Jorge Cortes, MD, director of the Georgia Cancer Center at Augusta University, said in a Rafael Pharmaceuticals-issued press release. “We were all hoping for positive results, and while this trial did not meet our expectations, we will continue to test devimistat in other studies.”