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Will The Recent Pipeline Progress Boost BMY's Portfolio Expansion?
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Key Takeaways
Bristol Myers Squibb's arlo-cel met the primary endpoint in heavily pretreated multiple myeloma.
Arlo-cel targets GPRC5D, offering a potential option after prior BCMA-directed treatment.
Bristol Myers Squibb is broadening its multiple myeloma portfolio with arlo-cel and Zenbexus.
Bristol Myers Squibb (BMY - Free Report) announced positive phase II results from the registrational QUINTESSENTIAL study evaluating arlocabtagene autoleucel (arlo-cel; BMS-986393) in heavily pretreated patients with relapsed and refractory multiple myeloma.
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.
The results are encouraging because arlo-cel targets GPRC5D, giving BMY an opportunity to treat patients already exposed to BCMA-directed therapies. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in quadruple-class exposed patients who had received at least four prior lines of therapy. The trial also met key secondary endpoints, including complete response rate (CRR), as well as ORR and CRR in patients who had received three or more prior lines of treatment.
Quadruple-class exposure consists of those who have been treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy and a BCMA-targeted therapy.
The findings are particularly relevant as treatment options for heavily pretreated multiple myeloma remain limited. As patients increasingly become resistant to multiple drug classes earlier in the treatment journey, therapies that work through alternative targets could have significant commercial potential.
Arlo-cel is also potentially differentiated as a single-infusion autologous CAR T therapy targeting GPRC5D, providing BMY with another potential growth opportunity in cell therapy and multiple myeloma.
Importantly, GPRC5D expression is independent of BCMA expression and can be maintained following prior BCMA-directed treatment, supporting the rationale for using arlo-cel after BCMA therapies.
While arlo-cel is still investigational, and additional clinical and regulatory milestones will be needed before its commercial opportunity can be fully assessed, the positive data potentially strengthens the company’s long-term multiple myeloma pipeline and could help diversify growth beyond its established portfolio.
BMY already has CAR T cell therapy Breyanzi in its portfolio. Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is approved for multiple blood cancers.
Last month, the FDA granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).
The regimen, approved under the brand name Zenbexus, is approved for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
Zenbexus is the first FDA-approved cereblon E3 ligase modulator, representing a novel class of cereblon-modulating protein degraders developed to treat multiple myeloma.
BMY is striving to broaden its portfolio to achieve sustained top-tier growth and maximize long-term value. The approval of new drugs brings an incremental stream of revenues to the company.
BMY Faces Competition for the CAR T Cell Therapy
Breyanzi faces competition from Gilead Sciences’ (GILD - Free Report) Yescarta for its approved indications.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is also approved for adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from FL.
GILD has another CAR T cell therapy in its franchise, Tecartus.
Another approved CAR T therapy is Novartis’ (NVS - Free Report) Kymriah, which is approved for acute lymphoblastic leukemia that is either relapsing or refractory. It is also used in patients with LBCL or FL, two types of non-Hodgkin lymphoma, who have relapsed or are refractory after undergoing at least two other kinds of treatment.
NVS’ Kymriah recorded sales of $169 million in the first half of 2026, down 15% from the year-ago period due to competitive pressure.
Per a Wall Street Journal article, Novartis paused eight clinical studies on investigational CAR T cell therapy, rap-cel, in late August, after three patients died.
BMY’s Price Performance, Valuation, Estimates and Zacks Rank
Shares of Bristol Myers Squibb have gained 19.9% year to date compared with the industry’s growth of 10.1%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, the stock currently trades at 9.85x forward earnings, higher than its mean of 8.53x but lower than the large-cap pharma industry’s 18.70x.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.86 from $6.32 in the past 60 days, while that for 2027 has increased to $6.44 from $6.09.
View the Zacks #1 Rank List
Image: Shutterstock
Will The Recent Pipeline Progress Boost BMY's Portfolio Expansion?
Key Takeaways
Bristol Myers Squibb (BMY - Free Report) announced positive phase II results from the registrational QUINTESSENTIAL study evaluating arlocabtagene autoleucel (arlo-cel; BMS-986393) in heavily pretreated patients with relapsed and refractory multiple myeloma.
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.
The results are encouraging because arlo-cel targets GPRC5D, giving BMY an opportunity to treat patients already exposed to BCMA-directed therapies. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in quadruple-class exposed patients who had received at least four prior lines of therapy. The trial also met key secondary endpoints, including complete response rate (CRR), as well as ORR and CRR in patients who had received three or more prior lines of treatment.
Quadruple-class exposure consists of those who have been treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy and a BCMA-targeted therapy.
The findings are particularly relevant as treatment options for heavily pretreated multiple myeloma remain limited. As patients increasingly become resistant to multiple drug classes earlier in the treatment journey, therapies that work through alternative targets could have significant commercial potential.
Arlo-cel is also potentially differentiated as a single-infusion autologous CAR T therapy targeting GPRC5D, providing BMY with another potential growth opportunity in cell therapy and multiple myeloma.
Importantly, GPRC5D expression is independent of BCMA expression and can be maintained following prior BCMA-directed treatment, supporting the rationale for using arlo-cel after BCMA therapies.
While arlo-cel is still investigational, and additional clinical and regulatory milestones will be needed before its commercial opportunity can be fully assessed, the positive data potentially strengthens the company’s long-term multiple myeloma pipeline and could help diversify growth beyond its established portfolio.
BMY already has CAR T cell therapy Breyanzi in its portfolio. Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is approved for multiple blood cancers.
Last month, the FDA granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).
The regimen, approved under the brand name Zenbexus, is approved for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
Zenbexus is the first FDA-approved cereblon E3 ligase modulator, representing a novel class of cereblon-modulating protein degraders developed to treat multiple myeloma.
BMY is striving to broaden its portfolio to achieve sustained top-tier growth and maximize long-term value. The approval of new drugs brings an incremental stream of revenues to the company.
BMY Faces Competition for the CAR T Cell Therapy
Breyanzi faces competition from Gilead Sciences’ (GILD - Free Report) Yescarta for its approved indications.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is also approved for adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from FL.
GILD has another CAR T cell therapy in its franchise, Tecartus.
Another approved CAR T therapy is Novartis’ (NVS - Free Report) Kymriah, which is approved for acute lymphoblastic leukemia that is either relapsing or refractory. It is also used in patients with LBCL or FL, two types of non-Hodgkin lymphoma, who have relapsed or are refractory after undergoing at least two other kinds of treatment.
NVS’ Kymriah recorded sales of $169 million in the first half of 2026, down 15% from the year-ago period due to competitive pressure.
Per a Wall Street Journal article, Novartis paused eight clinical studies on investigational CAR T cell therapy, rap-cel, in late August, after three patients died.
BMY’s Price Performance, Valuation, Estimates and Zacks Rank
Shares of Bristol Myers Squibb have gained 19.9% year to date compared with the industry’s growth of 10.1%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, the stock currently trades at 9.85x forward earnings, higher than its mean of 8.53x but lower than the large-cap pharma industry’s 18.70x.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.86 from $6.32 in the past 60 days, while that for 2027 has increased to $6.44 from $6.09.
Image Source: Zacks Investment Research
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.