Yahoo Finance Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo (Revised)
Bristol Myers Squibb BMY announced data from three studies evaluating CD19-directed CAR T cell therapy Breyanzi (liso-cel) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
These data include long-term data with three-year follow-up from the late-stage TRANSFORM study of Breyanzi as a second-line treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL). These also include results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by a number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and those from a subgroup analysis assessing the efficacy and safety of Breyanzi based on the use of bridging therapy in the TRANSCEND FL trial in relapsed or refractory follicular lymphoma (FL).
The three-year follow-up (at a median follow-up of 33.9 months) results from the TRANSFORM study showed sustained significant clinical benefit with continued improvements in the primary endpoint of event-free survival (EFS) with Breyanzi compared to standard of care (SoC) in LBCL patients. Clinical benefit was also observed in the secondary endpoints of progression-free survival (PFS), overall responses and duration of response (DOR) compared to SoC. The outcomes were consistent with the primary analysis results.
The MCL cohort of TRANSCEND NHL 001 enrolled adults with relapsed or refractory disease after two or more prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Results from a subgroup analysis from this cohort showed that Breyanzi demonstrated consistent clinical benefit, regardless of the number of prior lines of therapy. Breyanzi showed similar efficacy across most subgroups based on overall responses, complete responses (CR), median DOR, PFS and overall survival, including heavily-pretreated patients. The data supports the use of Breyanzi in earlier lines of treatment.
Data from bridging therapy subgroup analysis of TRANSCEND FL show consistent efficacy with high response rates and a consistent safety profile, regardless of receiving prior bridging therapy. The data supports Breyanzi’s differentiated profile in relapsed or refractory FL.
Breyanzi recently received accelerated approval from the FDA for adult patients with relapsed or refractory FL, who have received two or more prior lines of systemic therapy. The FDA also granted approval to Breyanzi for patients with relapsed or refractory MCL, who have received at least two prior lines of systemic therapy.
This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved.The new encouraging data at ASCO, which showed improved outcomes and consistent safety profile Breyanzi provides for diverse types of lymphoma patients, reinforced its potential and impressed investors.
BMY also announced positive results from three updated analyses from the CheckMate -77T, CheckMate -816, and CheckMate -9LA studies supporting Opdivo (nivolumab) and Opdivo-based combinations in early-stage and advanced non-small cell lung cancer (NSCLC) at ASCO.
The late-breaking exploratory analysis of the CheckMate -77T study of perioperative Opdivo shows improved EFS and pathologic CR in stage III resectable NSCLC patients regardless of nodal status.
Four-year follow-up data from the CheckMate -816 study reinforced treatment with neoadjuvant Opdivo, in combination with chemotherapy in patients with resectable NSCLC. Five-year follow-up data from the CheckMate -9LA study showed that Opdivo, plus Yervoy and chemotherapy, improves survival in patients with previously untreated metastatic NSCLC versus chemotherapy alone.
The company’s shares have lost 18.7% year to date compared with the industry's decline of 5.7%.
Image Source: Zacks Investment Research
Opdivo is one of the top drugs for BMY. Last week, the European Commission approved Opdivo in combination with a chemotherapy combination, cisplatin and gemcitabine, as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
Approval of new drugs and label expansion of the existing ones are imperative for BMY as it looks to expand its portfolio. One of the top drugs, Revlimid, is already facing generic competition, and Eliquis, too, is likely to face challenges later.
Hence, BMY is banking on Opdivo and newer drugs like Reblozyl and Opdualag to drive growth in the future.
The recent acquisitions of Mirati Therapeutics, Karuna Therapeutics, Inc. and RayzeBio should also aid the company’s efforts to expand its portfolio.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. KRYS, ALX Oncology Holdings ALXO and Minerva Neurosciences, Inc. NERV, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for KRYS’ earnings per share has increased 24 cents to $2.06. KRYS beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 21.46%. Shares of Krystal Biotech have surged 33.3% year to date.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60. Year to date, shares of NERV have lost 52.8%.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.
(We are reissuing this article to correct a mistake. The original article, issued on June 4, 2024, should no longer be relied upon.)
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
Minerva Neurosciences, Inc (NERV) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
ALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report
