AbbVie ABBV reported positive top-line data from the phase III CERVINO study, evaluating its investigational pipeline candidate, etentamig, in certain patients with relapsed/refractory multiple myeloma (RRMM) who had received prior treatment with three major drug classes.
The study is investigating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) for treating patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) RRMM.
The CERVINO study met both of its primary goals, showing that treatment with etentamig significantly improved the objective response rate (ORR) and progression-free survival (PFS) compared with standard available therapies.
Year to date, shares of AbbVie have risen 16.6% compared with the industry's growth of 17.6%.
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More on AbbVie's Phase III CERVINO Study Data
Data from the study showed that treatment with etentamig led to an ORR of 74% compared with 45.7% for SAT. It also reduced the risk of disease progression or death by 60%, with a PFS hazard ratio of 0.40. The PFS benefit was seen across all prespecified patient subgroups.
At 12 months, the overall survival rate was 87.9% for patients who were treated with etentamig compared with 72% for those receiving SAT. However, AbbVie noted that the prespecified statistical boundary for overall survival had not been crossed at the data cutoff date.
Etentamig also showed a manageable safety profile when given after a single step-up dose followed by monthly dosing. It also demonstrated low rates of cytokine release syndrome and fatal infections in the given patient population.
At the data cutoff, the CERVINO study included 393 patients who had received a median of three prior treatments. After a median follow-up of 11.4 months, treatment with etentamig showed statistically significant and clinically meaningful efficacy, while also demonstrating a manageable safety profile.
Per management, the results support the potential of etentamig, a BCMA-directed T-cell engager, to offer a convenient treatment option that could potentially be administered in outpatient and community-based settings.
AbbVie plans to discuss the results from the CERVINO study with regulatory authorities worldwide to decide the next steps of development for etentamig. The company also plans to present the data at a medical conference later this month.
ABBV Completes Acquisition of Apogee
In a separate press release, AbbVie announced that it has completed the previously announced acquisition of Apogee Therapeutics for approximately $10.9 billion.
The acquisition further strengthens AbbVie's dominant immunology pipeline by adding promising dermatology, respiratory and inflammatory disease assets supporting long-term growth.
ABBV's Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are RepligenRGEN, Anika TherapeuticsANIK and PrecigenPGEN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen's 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN's shares have gained 3.5% year to date.
Repligen's earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics' 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share, while estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK's shares have surged 118.6% year to date.
Anika Therapeutics' earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen's 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents, while estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN's shares have rallied 70.9% year to date.
Precigen's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
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This article originally published on Zacks Investment Research (zacks.com).
