J&J Highlights 2-Year Talvey Data in Multiple Myeloma at EHA24

Johnson & Johnson recently shared promising data regarding its drug Talvey (talquetamab-tgvs) at the European Hematology Association (EHA) annual meeting. The drug, evaluated in the MonumenTAL-1 Phase I/II study, demonstrated more than 60% two-year survival rates among triple-class-exposed patients with relapsed or refractory multiple myeloma. These patients had previously undergone extensive treatment.

Jordan Schecter, the leader in multiple myeloma research at Johnson & Johnson, emphasized Talvey's versatility, highlighting its multiple dosing options and its use before or after CAR-T therapy and BCMA bispecifics. This flexibility makes Talvey a significant advancement in treating multiple myeloma.

Talvey, which targets CD3 and GPRC5D, received accelerated FDA approval last year for patients heavily pretreated with multiple myeloma based on MonumenTAL-1 data. The study showed an overall response rate (ORR) of 73.6%, with 33% of patients achieving complete or better responses after about six months. The European Union also approved Talvey for fourth-line treatment shortly thereafter.

The MonumenTAL-1 study enrolled 297 patients who had not previously undergone T-cell redirection therapy. Participants received either 0.8 mg/kg of Talvey biweekly or 0.4 mg/kg weekly. Two years into the study, survival rates were 67.1% and 60.6% for the biweekly and weekly cohorts, respectively. For the biweekly group, the median duration of response (DOR) was 17.5 months, while it had not yet been reached for those achieving complete responses. In the weekly cohort, the median response duration was 9.5 months, but for those with a complete response, it extended to 28.6 months.

Leo Rasche, a myeloma specialist from the University Hospital of Würzburg, presented the findings and noted the absence of significant increases in treatment-related dropouts over the extended follow-up period.

In addition to MonumenTAL-1, Johnson & Johnson presented data from the Phase Ib MonumenTAL-2 study. This study evaluated Talvey in combination with pomalidomide in patients who had undergone at least two prior lines of therapy. With a median follow-up of nearly 17 months, the combination showed an ORR of 88.6%, with 80% achieving a very good partial response or better. The progression-free survival (PFS) rate at 12 months was 72.6%, and 80.4% of those with a complete response maintained it over this period.

Schecter highlighted the low rate of severe infections (Grade 3/4) in the MonumenTAL-2 study, suggesting Talvey's compatibility with immunomodulatory agents for patients with limited treatment options for this complex disease.

Johnson & Johnson has projected Talvey as one of seven key products anticipated to generate over $5 billion in revenue by 2030. This is especially significant as the company prepares for the impending patent expiration of its autoimmune drug, Stelara (ustekinumab).