#ASCO21: Watch out Bristol Myers, J&J is back at ASCO with some competitive BCMA CAR-T data
Bristol Myers Squibb and bluebird beat Johnson & Johnson to market back in March with their BCMA CAR-T drug, Abecma, for heavily pre-treated multiple myeloma patients. But watch out: J&J and their partners at Legend Biotech are now heading to ASCO with updated data that could give Abecma a run for its money.
A longer-term follow-up from the Phase Ib portion of a Phase Ib/II trial shows that all patients responded to J&J’s JNJ-4528, 86% of whom achieved a stringent complete response at a median of 11.5 months. In Phase II, there was a 95% overall response rate as of the February data cutoff, with a 75% stringent complete response, the company said Friday. The data are part of the package J&J is submitting in rolling applications for approvals in Europe and the US.
Jesus Berdeja, principal investigator of the study, said in a statement that it shows a “continued treatment effect for heavily pretreated patients who faced a dismal prognosis.” Multiple myeloma is a blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. While some patients achieve remission, most relapse, and 29% die within one year of diagnosis.
Patients in the Phase Ib portion of the study had received a median of five prior treatments (but ranged from three to 18 prior therapies). Most of them (86%) were triple-refractory, and 28% were penta-refractory. In Phase II, patients had a median of three lines of treatment.
“We’re encouraged by not only the relatively high rate of stringent complete responses, but also the progression-free survival seen in these patients,” Berdeja said.
A total of 85% of patients in the Phase II achieved what’s known as a “very good partial response” or better.
Back in December, upon scoring breakthrough therapy designation, J&J said 69% of patients had achieved a complete response. The new data measure stringent complete response, which is defined by the absence of two key markers of myeloma in the blood and bone marrow.
As with previous CAR-Ts, there is some risk. All patients in the Phase Ib experienced neutropenia, an abnormally low count of a type of white blood cell. And 93% experienced cytokine release syndrome (CRS). In the Phase II, CRS occurred in 85% of patients, with 10% experiencing a Grade 3 or 4 case. The median time of onset of CRS was 7 days, with a majority of patients only experiencing a Grade 1 or 2 event. At ASH in December, the companies said there were 14 deaths in the study, six of which were due to treatment-related events including CRS, sepsis, lung abscess, respiratory failure and neurotoxicity.
According to Mark Wildgust, Janssen’s VP of oncology global medical affairs, 99% of CRS was resolved within 14 days. “We see that predictable onset at about Day 7,” he told Endpoints News. “I don’t believe cytokine release is going to be an inhibition to use cilta-cel.”
J&J will continue to follow these patients for the long term, Wildgust said. But so far, these results best the data that led BMS and bluebird to an OK for Abecma, the first approved cell-based gene therapy for multiple myeloma.
Abecma put up a 72% overall response rate, with a 28% complete response rate. An estimated 65% of patients who achieved complete response remained there for at least 12 months, according to the FDA.
This story has been updated with Phase II results.