- Genmab has announced that its partner, Johnson & Johnson's Janssen Biotech, is stopping development of Darzalex (daratumumab) in relapsed or refractory non-Hodgkin's lymphoma (NHL) after the failure of the CARINA Phase 2 study.
- A data review of part 1 of the study showed that patients receiving the drug for relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma did not reach the predefined overall response rates of 50% and 30%, respectively. A third indication, mantle cell lymphoma, did not recruit enough patients for that part of the study to proceed due to the severity of disease in these patients.
- Despite the setback in NHL, development of Darzalex will continue in other tumor types, including multiple myeloma, where the drug already has approvals.
Darzalex, a monoclonal antibody targeted at CD38, failed to move forward in the high-risk indication, but will still play an integral role in combination therapies that are currently being tested.
"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 Jan van de Winkel, CEO of Genmab.
Development still moves forward for the drug, and Genmab has a handful of goals for 2017. Darzalex has conditional approval for second-line treatment of multiple myeloma in Europe under the European Medicines Agency's accelerated approval process, which requires further study before full approval. Genmab expects to get a decision from the EMA this year for second line and relapsed/refractory disease.
In the U.S., the monoclonal antibody is approved for use in heavily pretreated or double refractory multiple myeloma as a monotherapy or part of a combination therapy. It was the first monoclonal antibody for multiple myeloma to be approved in the U.S. , and has breakthrough designation for second-line treatment.
A 2017 goal for Genmab is the FDA decision on its use in a third line multiple myeloma setting with Celgene's Pomalyst (pomalidomide). Other plans for this year include an interim analysis of frontline treatment in multiple myeloma, and the start of a Phase 3 subcutaneous delivery study.
Combination studies are key in moving cancer therapies forward. Janssen has sponsored a Phase 1b study of Darzalex in combination with Genentech's anti-PDL1 antibody Tecentriq (atezolizumab) in solid tumors, and Genentech has sponsored a Phase 1b study of the combination in multiple myeloma. Other combination studies include a relapsed or refractory multiple myeloma study with Bristol-Myers Squibb's Opdivo (nivolumab).
Genmab originally developed Darzalex and licensed it to Janssen in August 2012 in return for an upfront fee of $55 million, along with an $80 million investment and up to $1 billion in development, regulatory and sales milestones. As of the end of 2016, Genmab had received $160 million in milestone payments and $65.8 million in royalties on sales of $572 million.