Join +750K new investors every month who copy stock picks from billionaire's portfoliosSign Up Free

What's Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?

Published 24/05/2024, 13:45
© Reuters.  What\'s Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?
AMGN
-
BMY
-
VSTM
-

Benzinga - by Vandana Singh, Benzinga Editor.

Thursday, Verastem Oncology (NASDAQ:VSTM) announced the initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the first-line in patients with metastatic pancreatic cancer.

The initial interim results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting.

As of May 14, patients receiving the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in dose level 1 cohort achieved a confirmed overall response rate (ORR) of 83% (5/6).

Of the 26 patients in all cohorts who have had the opportunity to have their first scan while on treatment, 21 have experienced a reduction of the change in target lesion sum of diameters.

One dose-limiting toxicity, febrile neutropenia (low white blood cell count), was observed in the dose level 1 cohort. The cohort was cleared after additional patients were evaluated.

In the additional dose cohorts enrolled more recently (-1, 1a, and 2a), follow-up is ongoing, and most patients remained on treatment at the data cutoff.

Verastem Oncology has established clinical collaborations with Amgen Inc (NASDAQ:AMGN) and Bristol-Myers Squibb Co (NYSE:BMY) Mirati to evaluate Lumakras (sotorasib) in combination with avutometinib and defactinib and Krazati (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the Phase 1b/2 RAMP 203 and RAMP 204 trials, respectively.

Friday, Verastem Oncology initiated the rolling submission of a New Drug Application (NDA) to the FDA seeking accelerated approval of the combination of avutometinib and defactinib for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy.

FDA has accepted Verastem’s plan to submit the clinical module in the second half of 2024 to complete the NDA application.

The company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.

The company is currently enrolling patients and activating sites for RAMP 301, an international confirmatory Phase 3 trial, evaluating the avutometinib and defactinib combination versus standard of care chemotherapy or hormonal therapy for KRAS mt and KRAS wt recurrent LGSOC.

Price Action: VSTM shares are down 59% at $4.99 during the premarket session at last check Friday after it surged as high as $19.74.

Photo by Aunt Spray via Shutterstock

© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read the original article on Benzinga

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.