Drug Development

J&J pulls the plug on PhII study for NHL after Darzalex falls short

Genmab CEO Jan van de Winkel

A little more than a month ago Genmab CEO Jan van de Winkel was counting out Darzalex’s (daratumumab) megablockbuster future, insisting to analysts that the cancer therapy could go on to earn J&J — its commercial partner — $13 billion a year.

“It could work in other blood cancers as well as in solid tumours. So that means $13 billion potential if it would work in all the indications,” Van de Winkel told Reuters.

The CEO may have to walk some of that back now.

Thursday afternoon Genmab followed up saying that J&J $JNJ was pulling the plug on stage two of a mid-stage program regarding three types of relapsed or refractory non-Hodgkin’s lymphoma due to futility. That includes the use of daratumumab monotherapy in relapsed or refractory patients with follicular lymphoma and with diffuse large B-cell lymphoma. In the third cohort, ORR was not evaluable in patients with mantle cell lymphoma due to slow recruitment “driven by the aggressive nature of the disease in its final stages.”

Initially pushed back to the last line of defense after multiple drug failures, the FDA approved several combinations using Darzalex as a second-line therapy late last year.

“While we hoped that daratumumab as a monotherapy could potentially provide a new treatment option in NHL patients with a high unmet medical need, the preliminary activity profile seen was not sufficient for the study to continue. Daratumumab is still being investigated in a number of indications including multiple myeloma and other hematological cancers such as NK/T-cell lymphoma and myelodysplastic syndrome as well as in solid tumors,” said the CEO.

Other ongoing and planned studies with daratumumab in lymphomas and other cancers outside multiple myeloma will continue as planned, Genmab reported.


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