Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate in this heavily pretreated patient population who have been exposed to a prior BCMA-targeted therapy
QUINTESSENTIAL is the first pivotal trial to evaluate a therapy in quadruple-class exposed relapsed and refractory multiple myeloma patients following treatment with prior BCMA-targeted therapies
Arlocabtagene autoleucel is a potential best-in-class autologous GPRC5D-directed CAR T cell therapy
PRINCETON, N.J.--(BUSINESS WIRE)--$BMY #CARTCellTherapy--
Bristol Myers Squibb Announces Positive Topline Results from Registrational Phase 2 QUINTESSENTIAL Trial of the Potential First-in-Class GPRC5D-Directed CAR T Cell Therapy, Arlocabtagene Autoleucel, in Patients with Quadruple-Class Exposed Relapsed and Refractory Multiple Myeloma
Bristol Myers Squibb (NYSE: BMY) today announced positive Phase 2 results from the registrational QUINTESSENTIAL trial (NCT06297226) of arlocabtagene autoleucel (arlo-cel; BMS-986393) in adult patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM). Arlo-cel is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CAR T cell therapy. As a CAR T cell therapy designed to be administered as a single infusion,* arlo-cel potentially represents a differentiated approach for patients with heavily pretreated relapsed and refractory multiple myeloma.
Results show the study met its primary endpoint with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in patients with quadruple-class exposed RRMM who had received four or more prior lines of therapy. Quadruple-class exposed consists of those who had been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy.
The study also met the key secondary endpoint of complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and the key secondary endpoints of ORR and CRR after three or more prior lines of therapy. The safety profile of arlo-cel was consistent with that of other CAR T cell therapies and other GPRC5D-targeting therapies in multiple myeloma.
“As combination treatment regimens are now frequently used in earlier lines of therapy, an increasing number of people with multiple myeloma are quadruple-class exposed and resistant to currently available therapies earlier in the treatment journey, creating a critical need for new therapeutic approaches,” said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. “These topline results support arlo-cel's potential benefit for patients while showing a safety profile consistent with expectations. They underscore our continued innovation in multiple myeloma and highlight the value of targeting alternative proteins, like GPRC5D, with the power of cell therapy to transform outcomes, laying the foundation for arlo-cel to become an important treatment option for this emerging group of patients who have been exposed to prior BCMA-targeted therapies.”
Bristol Myers Squibb thanks the patients and investigators who are participating in the QUINTESSENTIAL clinical trial. Results from QUINTESSENTIAL will be presented at an upcoming medical meeting.
* The treatment process includes collection of T cells from the patient’s blood followed by bridging therapy, CAR T cell manufacturing, lymphodepleting chemotherapy and then arlo-cel administration and side-effect monitoring.
About QUINTESSENTIAL
QUINTESSENTIAL (NCT06297226) is a Phase 2, open-label, multicenter, single-arm study evaluating the efficacy and safety of arlocabtagene autoleucel (arlo-cel; BMS986393) in patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM). Quadruple-class exposed consists of those who have been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy. The trial included patients who had received prior treatment with CAR T cell therapies.
The primary endpoint of the study is overall response rate (ORR), defined as best overall response (BOR) of partial response (PR) or better in quadruple-class exposed patients who had received four or more prior lines of therapy. Key secondary endpoints include complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and ORR and CRR in quadruple-class exposed patients who had received three or more prior lines of therapy.
About Arlocabtagene Autoleucel
Arlocabtagene autoleucel (arlo-cel; BMS-986393) is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed chimeric antigen receptor (CAR) T cell therapy. GPRC5D is a receptor expressed on plasma cells in multiple myeloma, with limited expression on healthy cells, and is a validated therapeutic target in multiple myeloma. Its expression is independent of BCMA expression and is maintained even after prior BCMA-directed therapy. Arlo-cel is designed to recognize and bind to GPRC5D in order to target and eliminate GPRC5D-expressing myeloma cells.
Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy
A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.
Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy’s transformational potential.
The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that arlocabtagene autoleucel (arlo-cel; BMS-986393) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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