Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells. BMS, which holds the rights to manufacture and commercialize outside the US, is adding a manufacturing facility in Leiden, the Netherlands, making Abecma available to patients in the EU.
CARsgen has dosed first patient in its Phase 2 trial of BCMA CAR-T
CARsgen Therapeutics gained 12 % to HK$35.20 after dosing the first subject in its North American Phase 2 LUMMICAR trial of CT053, an autologous BCMA CAR T therapy to treat refractory and/or relapsed multiple myeloma. The company plans to make regulatory submissions for marketing approval to NMPA and FDA in 1H22 and 1H23, respectively.
Kymriah missed its primary endpoint of event-free survival in Phase 3
Novartis announced that its CD19 CAR-T therapy Kymriah tisagenlecleucel missed the primary endpoint of event-free survival in the Phase 3 BELINDA trial to treat relapsed or refractory second-line B cell non-Hodgkin’s lymphoma compared to standard of care. In June, CD19 CAR-T competitors Yescarta axicabtagene ciloleucel from Gilead Sciences and Breyanzi lisocabtagene maraleucel from BMS both showed statistically significant outcomes on event-free survival in Phase 3 trials of the same setting.
Poseida gains proof of concept for its solid tumor CAR-T P-PSMA-101
At the CAR-TCR Summit, Poseida Therapeutics presented preliminary Phase 1 data for P-PSMA-101 in mCPRC showing that the PSMA-targeting CAR T cell therapy led to complete tumor elimination in one of the nine treated patients and measurable declines in PSA levels in four others. Three of the heavily pretreated patients, who received a median of six prior therapies, achieved more than a 50% reduction in PSA levels with concordant improvements on PSMA-PET imaging. Investors were hoping for more. Over half of the patients in the study achieved some level of PSA decline, however the data failed to impress the investors, which led to 19% share price drop during the day of data presentation.