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AbbVie at ASCO: Early-Stage Data on ABT-414 and Rova-T

AbbVie Inc.ABBV was present at the ongoing annual meeting of the American Society of Clinical Oncology (ASCO) with early-stage data on a couple of its pipeline candidates - ABT-414 and rovalpituzumab tesirine (Rova-T). Both are antibody drug conjugates (ADC) - while ABT-414 is being investigated for epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM), Rova-T is being evaluated in patients with recurrent or refractory small cell lung cancer (SCLC), identified with high expression of delta-like protein 3 (DLL3).

Safety and preliminary efficacy results from an expansion cohort of one arm (Arm C) of a three-arm open-label phase I study on ABT-414 showed no dose-limiting toxicities and frequent, reversible ocular toxicities. Moreover, about 30% of patients treated with ABT-414 as monotherapy were progression free at six months.

According to information provided by AbbVie in its press release, amplified EGFR is the most common genetic mutation associated with malignant GBM, an aggressive brain cancer. Given the median survival of 15 months after diagnosis and two-year survival rate of 30%, there remains significant unmet need for a new treatment option for this type of brain cancer.

ABT-414 is currently in a randomized phase II study in patients with EGFR-amplified GBM.

Meanwhile, there was a lot of interest in the Rova-T data, considering AbbVie shelled out $5.8 billion and could pay up to an additional $4 billion (on the achievement of milestones) to Stemcentrx under an acquisition agreement.

New data on Rova-T from a phase Ia/Ib, multicenter, open label, dose escalation study showed a confirmed overall response rate (ORR) of 39% and clinical benefit rate (stable disease or better) of 89% in patients with recurrent or refractory SCLC, identified with high expression of DLL3.

Median overall survival was 5.8 months and a one-year overall survival (OS) rate of 32% was also observed in the recurrent/refractory second- and third-line patient population.

18% of evaluable patients experienced tumor shrinkage, while 68% achieved clinical benefit (having at least stable disease). Almost all the patients who responded to the treatment had elevated levels of DLL3 in their tumor.

According to information provided by AbbVie in its press release, SCLC is an aggressive, difficult-to-treat form of cancer that accounts for roughly 13-15% of all lung cancers. The 5-year survival rate for extensive-stage SCLC is less than 5% with limited treatment options available for the more than 234,000 people diagnosed every year with SCLC.

Rova-T is currently in a single-arm phase II pivotal study in patients with DLL3-positive SCLC that has worsened despite at least two prior therapies - according to AbbVie, Rova-T has blockbuster potential and could be launched in 2018.

AbbVie is a Zacks Rank #5 (Strong Sell) stock. Some better-ranked stocks in the health care sector include Pfizer Inc. PFE , Bristol-Myers Squibb Company BMY and Johnson & Johnson JNJ . While Pfizer and Bristol-Myers are Zacks Rank #1 (Strong Buy) stocks, Johnson & Johnson is a Zacks Rank #2 (Buy) stock.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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