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Verastem (VSTM) Up 8% on Fast Track Tag for NSCLC Combo Therapy

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Verastem Oncology (VSTM - Free Report) announced that the FDA has granted the Fast Track designation to its investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s (AMGN - Free Report) Lumakras (sotorasib), for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC).

The FDA’s Fast Track designations intend to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions.

The Fast Track tag enables close communication between the FDA and sponsor in improving the efficiency of product development to get new therapeutics to patients faster.

Per Verastem, the combination therapy of avutometinib and Lumakras has demonstrated meaningful improvements, including deeper tumor regression and a decrease in the frequency of relapse of tumors, compared with Lumakras monotherapy in pre-clinical proof-of-concept studies.

The company’s stock gained 7.5% in the last trading session following the news.  as the investors cheered the regulatory update from the NSCLC study. Shares of Verastem have rallied 57.7% in the past year against the industry’s 15.2% decline.

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The company’s ongoing RAMP 203 clinical development program for avutometinib plus Lumakras is evaluating the clinical benefit of the combination therapy in KRAS G12C-mutant locally advanced or metastatic (la/m) NSCLC patients. The NSCLC patient population includes those who have received prior therapy for metastatic disease and have not been previously treated with a KRAS G12C inhibitor.

Per initial results from the phase I/II RAMP 203 study, both KRAS G12C-mutant NSCLC patient populations, those previously treated and untreated with a KRAS G12C inhibitor, demonstrated confirmed responses upon treatment with the avutometinib/Lumakras combo. The early to mid-stage study is evaluating the safety and efficacy of the combination therapy for the NSCLC indication.

In the RAMP 203 study, the company also observed that the pharmacokinetic profile of the combo regimen was similar to the results in the Lumakras monotherapy studies.The avutometinib and sotorasib combination therapy did not demonstrate any drug-drug interactions. 

Verastem is currently enrolling KRAS G12C inhibitor-resistant and naïve KRAS G12C-mutant NSCLC patients in the expansion phase of the RAMP 203 study. Updated results from the study are expected in the first half of 2024.

Verastem is simultaneously evaluating avutometinib for other cancer indications. 

Amgen’s Lumakras is a KRAS G12C inhibitor. The drug received the FDA’s accelerated approval in 2021, as determined by an FDA-approved test, for the treatment of adult patients with KRAS G12C-mutated la/m NSCLC who have received at least one prior systemic therapy. 

The FDA’s accelerated approval for the oral once-daily 960 mg of Lumakras was based on the positive overall response rate and duration of response results observed in Amgen’s CodeBreaK 100 study. The full approval of the drug for the NSCLC indication is contingent upon the success of a confirmatory study.

Amgen’s Lumakras is also currently approved in the EU and several other countries for the same NSCLC indication. The company is simultaneously evaluating Lumakras in multiple other solid tumors.

Zacks Rank and Stocks to Consider

Verastem currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same industry worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 5.8%.

PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.

In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have risen 47.4%.

ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%. 

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