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Bristol Myers (BMY) Stops Late-Stage Colorectal Cancer Study
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Bristol Myers Squibb (BMY - Free Report) suffered a setback as it decided to discontinue the late-stage study RELATIVITY-123.
This phase III randomized, open-label, multi-center trial was evaluating the fixed-dose combination of Opdivo (nivolumab) and relatlimab compared with Stivarga (regorafenib) or trifluridine plus tipiracil (TAS-102) in approximately 700 adult patients with microsatellite stable (“MSS”) metastatic colorectal cancer whose disease has progressed following at least one but no more than four prior lines of therapy for metastatic disease.
Based on a planned analysis conducted by an independent data monitoring committee, the study was discontinued as it was unlikely to meet its primary endpoints upon completion.
Bristol Myers, however, stated that the recommendation to stop the study was not based on safety concerns. The safety profile was consistent with previously reported studies of the fixed-dose combination of nivolumab and relatlimab.
While there are advanced treatments available for patients with microsatellite instability-high/deficient mismatch repair colorectal cancers, patients with MSS tumors continue to have limited treatment options in later lines of therapy.
Nevertheless, the company continues to evaluate the fixed-dose combination of nivolumab and relatlimab as a treatment for other tumor types as planned.
We remind investors that the combination of nivolumab and relatlimab is approved under the brand name Odualag for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma in the United States.
The discontinuation of the RELATIVITY-123 study will not impact this approved indication.
Relatlimab, a lymphocyte-activation gene 3-blocking antibody, is also being evaluated in clinical trials in combination with other agents in a variety of tumor types.
BMY shares have lost 29.1% year to date compared with the industry's decline of 17.6%.
Image Source: Zacks Investment Research
The approval of additional new drugs and the label expansion of existing ones is essential for the firm as it looks to diversify its product base and offset the slowdown in top-line growth as blockbuster multiple myeloma drug Revlimid and blood thinner medicine Eliquis face generic competition.
Bristol Myers and partner 2seventy bio, Inc. (TSVT - Free Report) recently faced a setback when the FDA informed the companies that the regulatory body would not be able to give a decision on the supplemental Biologics License Application (“sBLA”) for Abecma (idecabtagene vicleucel) by the original target date of Dec 16, 2023.
The sBLA is seeking approval of Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma based on results from the phase III KarMMa-3 study.
Both companies announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) will meet to review data supporting the sBLA for Abecma. However, the FDA has not yet confirmed the date of the ODAC meeting.
Bristol Myers Squibb and 2seventy bio also plan to discuss with the FDA and participate in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed relapsed or refractory multiple myeloma in earlier lines of treatment.
The company recently obtained FDA’s approval for repotrectinib, a tyrosine kinase inhibitor targeting ROS1 oncogenic fusions, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer under the brand name Augtyro.
While the firm's recent steps to boost its portfolio are encouraging, it needs to continue making efforts to offset the decline in Revlimid and Eliquis revenues.
Opdivo maintains momentum for the company and new drugs like Opdulag have witnessed robust uptake, too, but the loss of Revlimid revenues will weigh on the top line.
Entrada’s loss per share estimate for 2023 has narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.
Dynavax’s loss per share estimate for 2023 has narrowed from 23 cents to 12 cents in the past 30 days. Earnings estimate for 2024 rose from 3 cents to 18 cents during the same period. Shares of DVAX have gained 28.4% year to date.
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Bristol Myers (BMY) Stops Late-Stage Colorectal Cancer Study
Bristol Myers Squibb (BMY - Free Report) suffered a setback as it decided to discontinue the late-stage study RELATIVITY-123.
This phase III randomized, open-label, multi-center trial was evaluating the fixed-dose combination of Opdivo (nivolumab) and relatlimab compared with Stivarga (regorafenib) or trifluridine plus tipiracil (TAS-102) in approximately 700 adult patients with microsatellite stable (“MSS”) metastatic colorectal cancer whose disease has progressed following at least one but no more than four prior lines of therapy for metastatic disease.
Based on a planned analysis conducted by an independent data monitoring committee, the study was discontinued as it was unlikely to meet its primary endpoints upon completion.
Bristol Myers, however, stated that the recommendation to stop the study was not based on safety concerns. The safety profile was consistent with previously reported studies of the fixed-dose combination of nivolumab and relatlimab.
While there are advanced treatments available for patients with microsatellite instability-high/deficient mismatch repair colorectal cancers, patients with MSS tumors continue to have limited treatment options in later lines of therapy.
Nevertheless, the company continues to evaluate the fixed-dose combination of nivolumab and relatlimab as a treatment for other tumor types as planned.
We remind investors that the combination of nivolumab and relatlimab is approved under the brand name Odualag for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma in the United States.
The discontinuation of the RELATIVITY-123 study will not impact this approved indication.
Relatlimab, a lymphocyte-activation gene 3-blocking antibody, is also being evaluated in clinical trials in combination with other agents in a variety of tumor types.
BMY shares have lost 29.1% year to date compared with the industry's decline of 17.6%.
Image Source: Zacks Investment Research
The approval of additional new drugs and the label expansion of existing ones is essential for the firm as it looks to diversify its product base and offset the slowdown in top-line growth as blockbuster multiple myeloma drug Revlimid and blood thinner medicine Eliquis face generic competition.
Bristol Myers and partner 2seventy bio, Inc. (TSVT - Free Report) recently faced a setback when the FDA informed the companies that the regulatory body would not be able to give a decision on the supplemental Biologics License Application (“sBLA”) for Abecma (idecabtagene vicleucel) by the original target date of Dec 16, 2023.
The sBLA is seeking approval of Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma based on results from the phase III KarMMa-3 study.
Both companies announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) will meet to review data supporting the sBLA for Abecma. However, the FDA has not yet confirmed the date of the ODAC meeting.
Bristol Myers Squibb and 2seventy bio also plan to discuss with the FDA and participate in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed relapsed or refractory multiple myeloma in earlier lines of treatment.
The company recently obtained FDA’s approval for repotrectinib, a tyrosine kinase inhibitor targeting ROS1 oncogenic fusions, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer under the brand name Augtyro.
While the firm's recent steps to boost its portfolio are encouraging, it needs to continue making efforts to offset the decline in Revlimid and Eliquis revenues.
Opdivo maintains momentum for the company and new drugs like Opdulag have witnessed robust uptake, too, but the loss of Revlimid revenues will weigh on the top line.
Zacks Rank and Stocks to Consider
BMY currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Entrada Therapeutics (TRDA - Free Report) and Dynavax Technologies (DVAX - Free Report) . TRDA sports a Zacks Rank #1 (Strong Buy) and DVAX carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2023 has narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.
Dynavax’s loss per share estimate for 2023 has narrowed from 23 cents to 12 cents in the past 30 days. Earnings estimate for 2024 rose from 3 cents to 18 cents during the same period. Shares of DVAX have gained 28.4% year to date.