ASCO Annual Meeting
ASCO Annual Meeting
Perspective from Srinivas Devarakonda, MD
Source/Disclosures
Source:

Munshi NC, et al. Abstract 8503. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.

Disclosures: Bristol-Myers Squibb and bluebird bio supported this study. Munshi reports stock and other ownership interests in OncoPep; consultant/advisory roles with AbbVie, Adaptive Biotechnologies, Amgen, BeiGene, Bristol-Myers Squibb, Celgene, Janssen, Karyopharm Therapeutics, OncoPep and Takeda; and patents, royalties and other intellectual property with OncoPep. Please see the abstract for all other researchers’ relevant financial disclosures.
May 31, 2020
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BCMA-targeted CAR-T shows ‘outstanding responses’ in advanced multiple myeloma

Perspective from Srinivas Devarakonda, MD
Source/Disclosures
Source:

Munshi NC, et al. Abstract 8503. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.

Disclosures: Bristol-Myers Squibb and bluebird bio supported this study. Munshi reports stock and other ownership interests in OncoPep; consultant/advisory roles with AbbVie, Adaptive Biotechnologies, Amgen, BeiGene, Bristol-Myers Squibb, Celgene, Janssen, Karyopharm Therapeutics, OncoPep and Takeda; and patents, royalties and other intellectual property with OncoPep. Please see the abstract for all other researchers’ relevant financial disclosures.
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Idecabtagene vicleucel induced responses in nearly three-quarters of patients with relapsed or refractory multiple myeloma, according to initial results of the phase 2 KarMMa trial presented during the ASCO20 Virtual Scientific Program.

Higher doses of the investigational, autologous chimeric antigen receptor T-cell therapy led to increased response rates, results showed.

“The response rates with idecabtagene vicleucel were extremely clinically meaningful,” Nikhil C. Munshi, MD, associate professor of medical oncology at Dana-Farber Cancer Institute, told Healio. “For these patients to show deep and durable responses of this magnitude is quite impressive.”

Nikhil C. Munshi, MD
Nikhil C. Munshi

Idecabtagene vicleucel (bb2121; bluebird bio, Bristol-Myers Squibb) targets the B-cell maturation antigen expressed on the surface of cancer cells.

Idecabtagene vicleucel induced responses in nearly three-quarters of patients with relapsed or refractory multiple myeloma

A total of 128 patients (median age 61 years; range, 33-78; 59% men) in the pivotal KarMMa trial received idecabtagene vicleucel at one of three dose levels. Patients had received a median six (range, 3-16) previous therapies, and 84% were triple-refractory to common treatments, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody. Most patients (88%) received bridging therapy.

Overall response rate served as the primary endpoint. Secondary endpoints included complete response rate, duration of response, PFS and OS.

Median follow-up was 13.3 months across all dose levels, with data cutoff on Jan. 14.

Results showed an ORR of 73% (95% CI, 65.8-81.1) and a complete response rate of 33% (95% CI, 24.7-40.9). Median time to complete response was 2.8 months (range, 1-11.8).

Twenty percent of patients had very good partial responses and 21% had partial responses to therapy.

To put the results into perspective, Munshi said the typical ORR is 25% to 30% with currently available therapies for advanced multiple myeloma.

“This means that [idecabtagene vicleucel] has led to outstanding responses that far exceed anything else we have tried before in this group of patients,” he said.

Median duration of response was 10.7 months (95% CI, 9-11.3).

Survival data showed median PFS of 8.8 months (95% CI, 5.6-11.6) and median OS of 19.4 months (95% CI, 18.2 to not estimable) among all patients treated with idecabtagene vicleucel.

Both ORR and PFS increased substantially with higher doses of treatment. ORRs ranged from 50% with the lowest dose (150 × 106 CAR T cells/kg) to 82% with the highest dose (450 × 106 CAR T cells/kg). PFS ranged from a median 2.8 months (95% CI, 1 to not estimable) with the lowest dose to a median 12.1 months (95% CI, 8.8-12.3) with the highest dose.

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Researchers deemed the highest dose of idecabtagene vicleucel to be the optimal dose.

The safety analysis showed most patients (84%) experienced cytokine release syndrome (CRS), but fewer than 6% had grade 3 or higher CRS.

Twenty-three patients (18%) developed neurotoxicity after infusion, with less than 6% experiencing grade 3 or higher neurotoxicity.

CAR T-cell persistence appeared durable, with infused cells detected in 59% of patients at 6 months and 36% at 12 months.

Munshi noted that patients who had complete responses to therapy tended to have more durable responses, as well. He added that patients who responded to therapy had a significantly higher number of CAR T cells in their circulation that those who did not respond.

The manufacturers submitted a biologics license application for idecabtagene vicleucel to the FDA, which responded with a refusal to file letter requesting more information regarding the Chemistry, Manufacturing and Control module of the application.

Nevertheless, Munshi said he is confident idecabtagene vicleucel will achieve FDA approval for patients with relapsed or refractory multiple myeloma.

“The clinical data is not the issue with the study,” he told Healio. “This treatment has a very good chance of being approved because it is showing outstanding response rates in this patient population.”