bristol myers squib BMY experienced a setback when it decided to cancel the late-stage trial RELATIVITY-123.
In this Phase III, randomized, open-label, multicenter study, approximately 700 adult patients with stable microsatellites received a fixed-dose combination of Opdivo (nivolumab) and leratorimab, combined with Stivarga (regorafenib) or It was evaluated in comparison with trifluridine + tipiracil (TAS-102). (“MSS”) Metastatic Colorectal Cancer. Progression after at least one, but no more than four, previous treatments for metastatic disease.
Based on the planned analysis conducted by an independent data monitoring committee, the study was discontinued as it was unlikely to meet the primary endpoint upon completion.
However, Bristol-Myers said its recommendation to halt the study was not based on safety concerns. The safety profile was consistent with previously reported studies of fixed-dose combinations of nivolumab and leratlimab.
Although there are advanced treatments available for patients with mismatch repair colorectal cancers with high/deficient microsatellite instability, patients with MSS tumors continue to have limited treatment options for subsequent therapy.
Nevertheless, the company continues to evaluate the fixed-dose combination of nivolumab and leratorimab as a treatment for other tumor types as planned.
We would like to inform investors that in the United States, the combination of nivolumab and leratolimab is approved under the trade name Odualag for the treatment of adult and pediatric patients aged 12 years and older with unresectable or metastatic melanoma. .
Discontinuation of the RELATIVITY-123 study does not affect this approved indication.
Relatlimab, a lymphocyte activation gene 3 inhibitory antibody, is also being evaluated in clinical trials in combination with other drugs in a variety of tumor types.
BMY stock has declined 29.1% since the beginning of the year, compared to the industry’s decline of 17.6%.
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The addition comes as the company looks to diversify its product base and offset slowing sales growth as its multiple myeloma drug Revlimid and anticoagulant Eliquis face generic competition. Approval of new drugs and expansion of labels for existing drugs are essential.
Partner with Bristol Myers 2seventy bio, Inc. TSVT recently advised that the FDA would not be able to issue a decision on the supplemental biological products license application (“sBLA”) for Abecma (idecabtagene vicleucel) by the original target date of December 16, 2023. I faced setbacks for giving notice. .
sBLA is seeking approval of Abecma for early strains of triple-class exposed relapsed or refractory multiple myeloma based on results from the Phase III KarMMa-3 trial.
The companies announced that the FDA’s Oncology Drugs Advisory Committee (“ODAC”) will meet to review the data supporting Abecma’s sBLA. However, FDA has not yet confirmed the date of the ODAC meeting.
Bristol-Myers Squibb and 2seventy Bio are also in discussions with the FDA to explore Abecma’s potential to significantly improve outcomes for patients with relapsed or refractory multiple myeloma exposed to triple-class therapy in earlier lines of therapy. We plan to participate in the ODAC meeting to strengthen this.
The company recently received approval for repotrectinib, a tyrosine kinase inhibitor that targets ROS1 oncogenic fusions, under the trade name Augtyro, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Retrieved from FDA.
The company’s recent efforts to strengthen its portfolio are encouraging, but it must continue to make up for the decline in Revlimid and Eliquis revenues.
Opdivo continues the company’s momentum, and new drugs like Opdurag are also showing solid uptake, but lower revenue from Revlimid will weigh on sales.
Zacks Rank and Stocks to Consider
BMY currently carries a Zacks Rank #3 (Hold).
There are some better-ranked stocks across the healthcare sector. Entrada Therapeutics TRDA and Dynavax Technologies DVAX. Currently, TRDA sports a Zacks Rank #1 (Strong Buy) and DVAX has a Zacks Rank #2 (Buy).You can view See the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s 2023 loss per share estimate has narrowed from $2.07 to 9 cents over the past 60 days. In 2024, it shrunk from $2.35 to $2.04 within the same period.
Dynavax’s 2023 loss per share estimate has narrowed from 23 cents to 12 cents over the past 30 days. Earnings estimates for 2024 rose from 3 cents to 18 cents over the same period. DVAX stock has increased 28.4% since the beginning of the year.
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