EHA24: J&J touts 2-year data for Talvey bispecific in multiple myeloma

14 Jun 2024
firstwordpharma.com
Clinical ResultDrug ApprovalAccelerated ApprovalCell TherapyImmunotherapy
Johnson & Johnson said Friday that Talvey (talquetamab-tgvs) was associated with 2-year survival rates of over 60% in triple-class-exposed patients with relapsed or refractory multiple myeloma. That's according to updated results from the Phase I/II MonumenTAL-1 study presented at the European Hematology Association (EHA) annual meeting.
"With multiple dosing options and the ability to be used both before or after CAR-T therapy and BCMA bispecifics, Talvey is an important and versatile treatment option," said Jordan Schecter, the company's disease area leader for multiple myeloma.
The antibody, which is directed against CD3 and GPRC5D, was granted an accelerated approval by the FDA last year for fifth-line patients with heavily pretreated multiple myeloma based on data from MonumenTAL-1 showing an overall response rate (ORR) of 73.6%, including 33% complete or better responses after a median of nearly 6 months. An approval in the EU followed soon after in the fourth-line setting.
No increases in dropouts
The study included 297 patients with no prior exposure to T-cell redirection therapy who received the recommended Phase II dose of 0.8 mg/kg administered biweekly, or 0.4 mg/kg on a weekly schedule. At two years, 67.1% and 60.6% of patients were alive from the two dosing cohorts, respectively.
Patients in the biweekly cohort had a median duration of response (DOR) of 17.5 months, while the median was yet to be reached in patients achieving a complete response or better. For the weekly cohort, after a median follow-up of nearly 2.5 years, the median response duration was 9.5 months, and for those with a complete response or better, it was 28.6 months.
Leo Rasche, a physician on the myeloma service at the University Hospital of Würzburg who presented the results, said "it is encouraging to see no notable increases in treatment-related discontinuations with this longer follow-up across cohorts."
Combo with pomalidomide
Johnson & Johnson also unveiled data from 35 patients in the Phase Ib MonumenTAL-2 study, which is testing Talvey plus pomalidomide among those who have received at least two prior lines of therapy. With a median follow-up of nearly 17 months, the combo demonstrated an ORR of 88.6% in response-evaluable patients, with 80% achieving a very good partial response or better.
Further, the 12-month PFS rate in MonumenTAL-2 was 72.6%, while 80.4% of those who achieved a complete response or better maintained their response over that time.
"The low rate of Grade 3/4 infections seen in MonumenTAL-2 suggests the flexibility of Talvey as a combination partner with an immunomodulatory agent for patients who continue to face limited treatment options with this complex haematologic disease," Schecter added.
Johnson & Johnson has positioned Talvey as one of seven of its currently approved products to meet or exceed $5 billion in revenue by 2030, while also helping to fill the gap that will be left by its autoimmune drug Stelara (ustekinumab) as it heads toward a patent cliff. For related analysis, see – Vital Signs: Bispecifics challenge CAR-T in the BCMA revenue race and Physician Views In-Depth: Following label expansion, Carvykti leads the pack for 2L treatment of MM.
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