GFH375 shows 68.8% response rate in non-small cell lung cancer study

Published 13/08/2025, 21:34
GFH375 shows 68.8% response rate in non-small cell lung cancer study

BOSTON - Verastem Oncology (NASDAQ:VSTM), whose stock has surged over 229% in the past year and currently trades at $8.01, announced updated data from partner GenFleet Therapeutics’ Phase 1/2 study of GFH375, an oral KRAS G12D inhibitor, showing a 68.8% overall response rate in non-small cell lung cancer (NSCLC) patients at the recommended Phase 2 dose. According to InvestingPro analysis, the company, now valued at approximately $499 million, appears overvalued at current levels.

The data, which will be presented at the IASLC 2025 World Conference on Lung Cancer in Barcelona on September 7, demonstrated a 57.7% response rate across all dose levels in NSCLC patients with KRAS G12D mutations. While the clinical results are promising, InvestingPro data reveals the company is quickly burning through cash, though it maintains more cash than debt on its balance sheet. Discover 11 more exclusive ProTips and comprehensive analysis with an InvestingPro subscription.

The study included 142 patients, with 28 having advanced NSCLC. Among the NSCLC patients, all had metastatic disease, 64.3% had received at least two prior lines of therapy, and 96.4% had previously received anti-PD1/PD-L1 treatment.

At the recommended 600 mg once-daily dose, the disease control rate reached 93.8% in NSCLC patients. Across all dose levels, NSCLC patients showed an 88.5% disease control rate.

The most common treatment-related adverse events included diarrhea, vomiting, nausea, and anemia, primarily Grade 1 or 2 in severity. Severe adverse events occurred in 7.7% of patients, with six patients discontinuing treatment due to adverse events. No treatment-related deaths were reported.

KRAS G12D is the most prevalent KRAS mutation in human cancers, representing 26% of all KRAS mutations. It occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers.

Verastem Oncology, which has development and commercialization rights to VS-7375 (GFH375) outside China, Hong Kong, Macau, and Taiwan, initiated a Phase 1/2a clinical trial in the United States in June 2025 following FDA clearance of its Investigational New Drug application in April. Analysts maintain an optimistic outlook, with price targets ranging from $13 to $20, suggesting significant upside potential. Get detailed insights and access to the full Pro Research Report for VSTM, along with 1,400+ other stocks, exclusively on InvestingPro.

The data was presented in a press release statement from Verastem Oncology.

In other recent news, Verastem Inc. reported its financial results for the second quarter of 2025, revealing a net product revenue of $2.1 million following the launch of its new cancer therapy. Despite the revenue growth, the company experienced a non-GAAP adjusted net loss of $41.4 million. Verastem also bolstered its financial standing with a $75 million private placement. The company’s recent developments include the FDA approval of its new cancer therapy, which contributed to the revenue increase. These financial updates are crucial for investors monitoring Verastem’s progress in the biopharmaceutical sector.

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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