Verastem reports promising cancer drug trial results

Published 02/06/2025, 14:50
Verastem reports promising cancer drug trial results

BOSTON - Verastem Oncology (NASDAQ:VSTM), a biopharmaceutical company with a market capitalization of $418 million, has announced positive results from a Phase 1/2 trial of its drug GFH375, also known as VS-7375 in the U.S., for treating certain cancers. The company’s stock has shown remarkable momentum, gaining nearly 90% over the past year, according to InvestingPro data. The data, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025, showed an overall response rate (ORR) of 52% in pancreatic ductal adenocarcinoma (PDAC) patients and 42% in non-small cell lung cancer (NSCLC) patients.

The trial, conducted in China by Verastem’s partner GenFleet Therapeutics, enrolled 62 patients, with the majority having metastatic disease and having undergone multiple prior therapies. While the company maintains a strong liquidity position with a current ratio of 3.5x and more cash than debt on its balance sheet, InvestingPro analysis indicates the company is rapidly burning through its cash reserves. As of May 16, 2025, those treated with 400 or 600 mg daily doses of GFH375 demonstrated a disease control rate (DCR) of 100% for PDAC and 83% for NSCLC.

No dose-limiting toxicities were observed across all dose levels, and treatment-related adverse events were mostly Grade 1/2, including diarrhea, nausea, vomiting, and anemia. The most severe adverse events were decreased neutrophil count and diarrhea, affecting 8% and 5% of patients, respectively.

Verastem is preparing to launch a Phase 1/2a study of VS-7375 in the U.S., focusing on advanced KRAS G12D mutant solid tumors. The company plans to build upon the initial results from the GenFleet study, aiming for deeper and more durable cancer responses. The starting dose for the U.S. trial will be 400 mg, based on the GenFleet study’s findings.

VS-7375 is described as a potent and selective oral KRAS G12D dual ON/OFF inhibitor, potentially offering improved efficacy over other KRAS G12D-selective agents. Verastem’s collaboration with GenFleet Therapeutics includes three discovery programs targeting RAS/MAPK pathway-driven cancers, with VS-7375 being the lead program.

The company will host an R&D investor webcast today at 11:00 am CDT to discuss the updated data from the RAMP 205 study and the development of VS-7375. The announcement is based on a press release statement.

In other recent news, Verastem Oncology has reported promising results from its RAMP 205 Phase 1/2 trial, which tested a combination therapy for treating metastatic pancreatic ductal adenocarcinoma. The trial’s selected dose cohort showed an 83% overall response rate, prompting the company to plan a Phase 3 study in 2026. This follows the recent FDA approval of the same combination therapy for treating recurrent KRAS-mutated low-grade serous ovarian cancer. Jefferies has responded to these developments by raising Verastem’s price target from $15 to $19, maintaining a Buy rating. Additionally, Mizuho analysts have kept an Outperform rating with an $8 price target, citing confidence in the company’s financial position and upcoming data releases. Verastem also secured $75 million in a private placement, which will help fund the launch of its approved therapies and ongoing research. The FDA has cleared Verastem’s new drug, VS-7375, for clinical trials targeting advanced solid tumors, with a Phase 1/2a study set to begin in mid-2025. This drug aims to address KRAS G12D mutations, which are prevalent in various cancers, marking another significant step in Verastem’s research efforts.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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