Health Canada Approves ABECMA™ (idecabtagene vicleucel), the First and Only Anti-BCMA CAR T cell Therapy for Relapsed and Refractory Multiple Myeloma

ABECMA^TM is the first personalized cell therapy available to Canadian patients for the treatment of adults with multiple myeloma who have received at least three prior therapies and who are refractory to their last treatment ¹

MONTREAL, May 31, 2021 /CNW/ - Bristol Myers Squibb Canada (BMS) today announced Health Canada has granted conditional approval (NOC/c) for ABECMA^TM (idecabtagene vicleucel; ide-cel) as the first and only B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for adults with multiple myeloma (MM). ABECMA^TM is indicated for MM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.² This conditional approval is based on the results of the pivotal Phase II KarMMa study which demonstrated ABECMA^TM's ability to deliver rapid, deep and durable responses with a single infusion.³

Learn more about multiple myeloma and ABECMA™. (CNW Group/Bristol Myers Squibb Canada Co.)

Learn more about cell therapy and ABECMA™. (CNW Group/Bristol Myers Squibb Canada Co.)

"Today's approval is an important milestone in the treatment of multiple myeloma in Canada," says Dr. Christine Chen, Medical Director of Clinical Immune Effector Cell Therapy at Princess Margaret Cancer Centre. "Unlike traditional treatments, ABECMA^TM is a one-time infusion. That means the therapy continues to put pressure on the disease while sparing patients the need for multiple treatment cycles. It offers them a treatment-free interval where they can experience a more normal life."

ABECMA^TM, a CAR T therapy, uses patients' T cells to create a personalized version of their own immune system, potentially improving the chances of anti-tumour response long after treatment administration.^4,5,6,7 As an anti-BCMA CAR T cell therapy, ABECMA^TM recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in MM, leading to the death of BCMA-expressing cells.⁸

"Nine Canadians are diagnosed with multiple myeloma every single day, but despite the growing prevalence, current treatment options are not enough and there continues to be a critical unmet need for patients who have received many therapies," says Martine Elias, Executive Director, Myeloma Canada. "Introducing CAR T therapy means there is now an important new option for Canadians living with advanced multiple myeloma."

MM is a hematologic cancer which develops when a buildup of malignant plasma cells forms in the bone marrow and limits the ability for other blood cells to develop and work normally.⁹ In 2020 alone, an estimated 3,400 Canadians were diagnosed with MM,¹⁰ and an estimated 7,460 currently live with MM.¹¹ An incurable disease that mutates over time, the natural progression of multiple myeloma is for patients to experience relapsed/refractory MM (RRMM). This results in an increased burden of disease and decreased depth and duration of response to each successive line of therapy.^{12,13,14,15,16,17} 

"ABECMA^TM is the first of a portfolio of CAR T therapies BMS currently has in development, addressing the needs of patients who have limited treatment options," says Al Reba, General Manager, Bristol Myers Squibb Canada. "Working with our network of treatment facilities across Canada, this approval is a critical step in our journey to bring innovative cell therapies to Canadians living with advanced blood cancers such as multiple myeloma."

Health Canada's approval of ABECMA^TM is based on the results of the Phase II KarMMa trial of 122 patients with RRMM who received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and who were refractory to their last treatment.¹⁸ The conditional approval is based upon the overall response rate, complete response rate, and durability of response.¹⁹ Patients included in the trial were heavily pretreated with 84% being refractory to all three classes of treatment.²⁰ The median duration of follow-up throughout the KarMMa trial was 13.3 months.²¹ ABECMA demonstrated an overall response rate of 74% and a complete response (CR) rate of 32%.²² The onset of response was rapid with a median time to response of one month.²³

Median duration of response was 11 months in those who achieved a partial response (PR) or better and 19 months for those who achieved a CR.²⁴ An improvement in progression-free survival or overall survival has not yet been established.²⁵

The safety profile of ABECMA^TM was generally manageable ²⁶ with, most adverse events occurring in the first 8 weeks of therapy, except for those of hypogammaglobulinemia and infections.²⁷ The most common nonlaboratory AEs included cytokine release syndrome (CRS), infections – pathogen unspecified, diarrhea, fatigue, nausea, viral infections, encephalopathy, pyrexia, cough, decreased appetite, headache, edema and hypogammaglobulinemia.²⁸ Serious AEs occurred in 67% of patients.²⁹ The most common serious AEs included CRS, general physical health deterioration, pneumonia, and febrile neutropenia.³⁰ The most common Grade 3 or 4 nonlaboratory AEs were febrile neutropenia and infections – pathogen unspecified.³¹ In patients with persistent neutropenia the median time to recovery was 1.9 months.³² In patients with persistent thrombocytopenia, the median time to recovery was 2.1 months.³³

About Bristol Myers Squibb Cell Therapy Research
Through novel manufacturing approaches and a well-established supply chain platform across a broad network of state-of-the-art facilities, BMS is advancing cell therapy research. Having established immunotherapy manufacturing facilities with cutting-edge technologies and highly trained manufacturing teams, BMS works to make cell therapy possible for Canadian patients in need.

BMS' investment into the use of next-generation technology to optimize the manufacturing process and capacity will serve to decrease complexities and turnaround time, improve product control and reduce manufacturing costs. These efforts ultimately reduce the cost of these novel therapies to ensure patients can receive their treatment as quickly and as safely as possible.

About Ide-cel
Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy.³⁴ The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA followed by a human CD8α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 (4-1BB) and CD3ζ chain, in tandem.³⁵ Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.³⁶

About Bristol Myers Squibb Canada
Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb global operations, visit www.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 400 people across the country. For more information, please visit www.bms.com/ca.

^1 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^2 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^3 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^4 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^5 Wang DY, Johnson DB, Davis EJ. Toxicities associated with PD-1/PD-L1 blockade. Cancer J. 2018;24(1):36-40.

^6 Davila ML, Riviere I, Wang X, et al. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014;6(224):224ra25.

^7 Teachey DT, Bishop MR, Maloney DG, Grupp SA. Toxicity management after chimeric antigen receptor T cell therapy: one size does not fit 'ALL.' Nat Rev Clin Oncol. 2018;15(4):218.

^8 ABECMA^TM Product Monograph. Bristol Myers Squibb. May 27, 2021.

^9 Canadian Cancer Society. Multiple Myeloma. Available at https://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/multiple-myeloma/?region=on. Accessed on February 5, 2021.

^10 Canadian Cancer Society. Multiple myeloma statistics. Available at https://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on. Accessed on February 5, 2021.

^11 Myeloma Canada | Statistics. Accessed March 17, 2021.

^12 Kumar S. Treatment of Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients. Current Hematologic Malignancy Reports. 2011;6(2):104-112. http://www.ncbi.nlm.nih.gov/pubmed/21394431.

^13 Kumar S K, Lee J H, Lahuerta J J, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: A multicenter international myeloma working group study. Leukemia. 2012;26(1):149-157. http://www.ncbi.nlm.nih.gov/pubmed/21799510.

^14 Nijhof I, Donk N, Zweegman S, Lokhorst H. Current and New Therapeutic Strategies for Relapsed and Refractory Multiple Myeloma: An Update. Drugs. 2018;78(1):19-37. http://www.ncbi.nlm.nih.gov/pubmed/29188449.

^15 Sonneveld P. Management of multiple myeloma in the relapsed/refractory patient. Hematology Am Soc Hematol Educ Program. 2017;2017(1):508-517. http://www.ncbi.nlm.nih.gov/pubmed/29222299.

^16 Sonneveld P. Management of multiple myeloma in the relapsed/refractory patient. Hematology Am Soc Hematol Educ Program. 2017;2017(1):508-517. http://www.ncbi.nlm.nih.gov/pubmed/29222299.

^17 Usmani SZ, Weiss BM, Plesner T, et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016;128(1):37-44. http://www.ncbi.nlm.nih.gov/pubmed/27216216.

^18 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^19 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^20 Munshi N, Anderson L, Shah N, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med 2021; 384(8): 705-716. https://www.nejm.org/doi/full/10.1056/NEJMoa2024850

^21 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^22 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^23 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^24 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^25 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^26 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^27 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^28 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^29 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^30 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^31 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^32 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^33 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^34 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^35 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

^36 ABECMA^TMProduct Monograph. Bristol Myers Squibb. May 27, 2021.

SOURCE Bristol Myers Squibb Canada Co.

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