As companies eagerly trumpet new data for their BCMA-targeted therapies at the American Society of Hematology (ASH) 2022 annual meeting, Bristol Myers Squibb’s much-anticipated third-line multiple myeloma data for Abecma were mysteriously missing.
Why?
ASH didn’t select the data as a late-breaking presentation, Sergio Giralt, M.D., who chairs multiple myeloma practice at Memorial Sloan Kettering Cancer Research Center and is an investigator in KarMMa-3, told Fierce Pharma. The data will be submitted to what’s known as the Tandem meetings, which are scheduled for February 2023 in Orlando, Florida, Giralt said.
The rejection raises questions around the quality of the KarMMa-3 data and whether they are good enough to change clinical practice. ASH chose six late-breaking abstracts for inclusion in the annual meeting, none of which were for CAR-T therapy.
In a statement to Fierce Pharma, an ASH media aide said the organization does not comment on abstracts that weren’t selected as late-breaking abstracts.
“The selection process is highly competitive as only six late-breaking abstracts are selected, representing the highest-impact abstracts featuring substantive, novel, and groundbreaking data that otherwise could not be presented at the annual meeting,” the media representative said.
Back in August, BMS said the trial hit its primary endpoint, showing the BMS CAR-T drug topped standard treatments at delaying tumor progression or death. The results could enable Abecma to move into earlier treatment in patients who have failed two prior lines of therapy. Currently, the drug is approved as a fifth-line treatment.
BMS has submitted the KarMMa-3 data to a peer-reviewed journal and will present the data at an upcoming medical conference that’s not ASH, Chief Medical Officer Samit Hirawat, M.D., said in an interview with Fierce Pharma ahead of the meeting. Bristol's conversations with the FDA and investigators are “in a good place," he added.
Abecma’s data delay comes as its rivals, Johnson & Johnson and Legend Biotech, await an imminent phase 3 readout for Carvykti as a second-line treatment. The pair hopes to report by the end of the year.
As for BMS, the company did share data from two cohorts in the phase 2 KarMMa-2 trial in earlier treatment settings at ASH 2022.
In a group of multiple myeloma patients who had progressed quickly within 18 months after front-line therapy involving stem cell transplant, Abecma triggered a complete response rate of 45.9% of participants. Altogether, 83.8% of patients responded to Abecma, with a median duration of response lasting 15.7 months. In those who achieved complete response, the median duration of response was 23.5 months.
At 24 months, investigators estimated that 84.7% patients would still be alive, which is better than historical treatment expectations, Krina Patel, M.D., from the MD Anderson Cancer Center said when presenting the data at ASH 2022.
In another cohort of patients who had inadequate response to first-line treatment involving stem cell transplant, Abecma recorded a complete response rate of 74.2% after a median follow-up of 27.5 months. Overall, 87.1% of patients enjoyed tumor shrinkage. At 24 months, investigators estimated that 92.1% of patients would still be responding to treatment.
These subgroup analyses won’t lead to any approvals because label expansions would require randomized trials, Hirawat said. The data are supportive for launching new clinical trials, and BMS does intend to look at the post-transplant setting, he added.
BMS is heavily invested in multiple myeloma. Besides Abecma, the company also has a BCMAxCD3 bispecific antibody, alnuctamab.
At ASH 2022, the company also unveiled first phase 1 data for a GPRC5D-targeted CAR-T therapy, BMS-986393, in a potential new battleground for pharmas—including Carvykti maker J&J—in myeloma. Among 33 patients treated with various doses of the therapy, cytokine release syndrome happened in 63.6% of patients, including 6.1% at grades 3 or 4. In patients who have previously received a BCMA-targeted treatment, BMS-986393 induced a 77.8% overall response rate.