Yahoo Finance Verastem (VSTM) Up on Upbeat Early Pancreatic Cancer Study Data
Verastem Oncology VSTM announced positive interim safety and efficacy data from the dose level 1 cohort of its early to mid-stage study evaluating avutometinib and defactinib in combination with standard-of-care first-line chemotherapy (gemcitabine and Nab-paclitaxel) in metastatic pancreatic cancer patients.
Both avutometinib and defactinib have been in-licensed by Verastem from other pharmaceutical companies. Avutometinib is an RAF/MEK clamp, while defactinib is a best-in-class selective FAK inhibitor.
The dose level 1 cohort of the ongoing phase I/II RAMP 205 study enrolled six patients who were administered 2.4 mg of avutometinib twice a week, 200 mg of defactinib twice a day for three weeks out of every four, along with 800 mg/m2 of gemcitabine and 125 mg/m2 of Nab-paclitaxel on a schedule of day one, day eight and day 15.
Per the data readout from this dosing regimen cohort, as of May 14, 2024, 83% of patients achieved a confirmed partial response, which translates to five out of the six treated patients, with more than six months of follow-up at the time of data cutoff.
Please note that Verastem reported one dose-limiting toxicity of febrile neutropenia in the dose level 1 cohort. However, the dose level was cleared after additional patients were enrolled in three other cohorts of the RAMP 205 study, where patients received different combinations of avutometinib and defactinib with gemcitabine and Nab-paclitaxel.
Verastem’s shares rallied 57.1% in the after-market hours on May 23 following the news release. The investors were impressed by the interim analysis efficacy and safety results from the pancreatic cancer study. The stock continued to gain significantly in the pre-market hours today. Year to date, Verastem shares have surged 49.6% against the industry’s 6% decline.
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Verastem is currently continuing to evaluate other doses and schedule regimens in the additional cohorts of the RAMP 205 study to determine the recommended phase II dose.
As of the data cutoff of May 14, 41 patients have been treated in either of the four dose and schedule cohort regimens of avutometinib and defactinib with gemcitabine and Nab-paclitaxel. The company did not share initial interim efficacy results from the other three cohorts as follow-up is ongoing.
However, there were 26 patients from all cohorts who had the opportunity to have their first scan while on treatment. A reduction of the change in target lesion sum of diameters was observed in 21 of the patients.
Verastem reported initial interim safety data from all dose cohorts as of May 14, evaluating the combination therapy for metastatic pancreatic cancer. It was observed that two patients had to discontinue treatment because of serious treatment-emergent adverse events, although several others experienced such adverse events.
Per the company, approximately 30,000 patients in the United States are diagnosed with metastatic pancreatic cancer annually, for which the five-year survival rate is 3%, depicting a very poor prognosis. Globally, the figure for diagnosed individuals is around 240,000. The current standard of care treatment regimen consists of surgery, chemotherapy, radiation or a combination of these approaches.
Please note that Verastem is also simultaneously evaluating avutometinib in combination regimens for other cancer indications.
Verastem, Inc. Price and Consensus
Verastem, Inc. price-consensus-chart | Verastem, Inc. Quote
Zacks Rank and Stocks to Consider
Verastem currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings ALXO, Annovis Bio ANVS and Entera Bio Ltd. ENTX. Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have lost 1.3%.
ALX Oncology beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.82 to $1.95. Year to date, shares of ANVS have plunged 62.1%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, Zacks Consensus Estimate for Entera Bio’s 2024 loss per share has remained constant at 25 cents. During the same period, the consensus estimate for 2025 loss per share has remained constant at 54 cents. Year to date, shares of ENTX have surged 285%.
ENTX’s earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 6.50%.
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