GSK Submits NDA in China for BCMA ADC Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma

▎Armstrong

On December 7, 2024, the marketing application for GSK's Mavrilimumab Injection was accepted by the NMPA.

Blenrep (Belantamab Mafodotin) received FDA accelerated approval in August 2020 for fifth-line and later treatment of relapsed or refractory multiple myeloma. The approval was based on the ORR and DOR data from the DREAMM-2 trial, as well as the CBR data from a randomized Phase III clinical trial.

Blenrep's antibody utilizes BioWa's POTELLIGENT technology from Kyowa Kirin's subsidiary, enhancing ADCC activity through defucosylation. For the ADC construct, a non-cleavable linker is used.Conjugated with auristatin F toxin, the linker was licensed from Seagen.

On November 7, 2022, GSK updated the latest data from the Phase III clinical trial DREAMM-3 of the BCMA ADC new drug Blenrep for the treatment of multiple myeloma.

DREAMM-3 enrolled 325 patients with relapsed refractory multiple myeloma, randomized 2:1 to the BCMA ADC group or the pomalidomide plus dexamethasone group, with PFS as the primary endpoint.

The results did not meet the primary endpoint of PFS, with an HR of 1.03 for the BCMA ADC group compared to the control group, mPFS of 11.2 months vs. 7 months, ORR of 41% vs. 36%, and 12-month DOR rates of 76.8% and 48.4%, respectively.

On November 27, 2023, GSK announced the success of the Phase III clinical trial DREAMM-7 for Blenrep, a BCMA ADC new drug, in second-line treatment of relapsed or refractory multiple myeloma, compared to...InCD38 Antibody Control Group, Significant Improvement in PFS and OS.

In June 2024, GSK announced the success of the Phase III clinical trial DREAMM-8 for Blenrep combination therapy as a second-line treatment for multiple myeloma, with PFS extending from 12.7 months to 21.8 months.

Summary

GSK is actively expanding its ADC layout. Blenrep has been resurrected, while externally, multiple ADCs are being introduced, including HANSOH PHARM's B7H3 ADC, B7H4 ADC, and Duality Biologics' DB-1324, among others.