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CAMBRIDGE, Mass. - Leap Therapeutics, Inc. (NASDAQ:LPTX), a clinical-stage biotech company with a market capitalization of $14.87 million and currently trading near its 52-week low, has announced updated results from its Phase 2 DeFianCe study of sirexatamab, an investigational cancer drug, showing improved outcomes in certain colorectal cancer (CRC) patients. The data, presented today, indicates that patients with high levels of DKK1 or those who have not had prior anti-VEGF therapy experienced better response rates and progression-free survival (PFS) when treated with sirexatamab in combination with bevacizumab and chemotherapy.
In the study subset with high DKK1 levels, the sirexatamab group saw a 32% higher overall response rate (ORR) and a 3.5-month longer median PFS compared to the control arm. The median overall survival (OS) has not yet been reached in this group, suggesting a potential for longer-term survival benefits.
For patients who had not received prior anti-VEGF therapy, the sirexatamab group demonstrated a 22% higher ORR and a 2.6-month longer median PFS. While the median OS data is not yet mature, early indicators show a favorable trend for the sirexatamab arm.
Across the entire intent-to-treat population, sirexatamab is associated with improved ORR compared to the control arm. The study continues as more patients in the sirexatamab arm remain on treatment, which could further differentiate the results.
The safety profile of the sirexatamab combination therapy aligns with previous studies, suggesting it is well tolerated. Based on these findings, Leap Therapeutics is considering a Phase 3 clinical trial to confirm sirexatamab’s efficacy and safety for second-line CRC treatment. According to InvestingPro data, while the company maintains a healthy current ratio of 3.97 and holds more cash than debt, it’s currently burning through cash rapidly - a crucial factor for investors monitoring clinical development progress.
With its stock down over 85% in the past six months, Leap Therapeutics is exploring business development opportunities to advance sirexatamab’s development, given the large market potential for CRC therapies. InvestingPro subscribers can access 13 additional key insights about LPTX’s financial health, valuation metrics, and growth potential to make more informed investment decisions. There are approximately 30,000 second-line treated CRC patients in the US, and a significant portion of these patients have high DKK1 levels or have not received prior anti-VEGF therapy.
The company will present these clinical findings in a conference call today at 8:00 a.m. Eastern Time. This update is based on a press release statement from Leap Therapeutics.
In other recent news, Leap Therapeutics has announced positive initial data from its DeFianCe study for advanced colorectal cancer (CRC), showing a higher objective response rate when its drug sirexatamab is used in combination with bevacizumab and chemotherapy. This Phase 2 trial demonstrated a 35% objective response rate in the experimental arm compared to 23% in the control arm, suggesting potential for a biomarker-driven approach to treatment. However, Leap Therapeutics also reported that its DisTinGuish study in advanced gastric cancer did not meet the necessary criteria to proceed to Phase 3, leading the company to halt plans for further studies in this indication. In response to these mixed outcomes, both H.C. Wainwright and Baird have downgraded their ratings for Leap Therapeutics from Buy and Outperform to Neutral, respectively. H.C. Wainwright cited concerns over the future progress of sirexatamab, while Baird noted the ambiguous survival data and deteriorating financial outlook. Leap Therapeutics plans to focus on advancing sirexatamab in CRC and is seeking strategic partnerships for its development in other indications. The company is preparing for a registrational Phase 3 study in second-line CRC patients, aiming to address high unmet needs and specific biomarker profiles. Despite the setbacks in gastric cancer, Leap Therapeutics remains optimistic about the potential of sirexatamab in CRC, with plans to report additional data as it matures over the coming months.
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