Genmab's lymphoma project flops in Phase III with Novartis holding the bag

Genmab's plans to develop ofatumumab for lymphoma came to a halt as the company pulled the plug early on a Phase III trial that was unlikely to meet its goals, souring an investment from partner Novartis ($NVS).

The company's independent data monitoring committee took a look at interim results in a trial comparing Genmab's antibody with Roche's ($RHHBY) Rituxan and concluded that following through with the study would be pointless. Taking the committee's advice, Genmab is now stopping the trial ahead of schedule.

The study enrolled 516 patients with follicular non-Hodgkin's lymphoma (NHL) to determine whether ofatumumab, which targets the cancer antigen CD20, could beat out Rituxan in extending progression-free survival over 9 months.

Novartis picked up the rights to ofatumumab's future in oncology in a sweeping, $16 billion asset swap with GlaxoSmithKline ($GSK) last year. The treatment's failure in NHL follows a 2014 Phase III failure in B-cell lymphoma, leaving chronic lymphocytic leukemia as ofatumumab's sole remaining cancer indication.

Novartis deepened its embrace of Genmab's treatment earlier this year, promising GSK as much as $1 billion more in exchange for the rights to develop the drug for autoimmune disease. Under that agreement, Novartis paid $300 million upfront, promising another $200 million once the treatment enters Phase III for multiple sclerosis and up to $534 million more tied to development milestones. Ofatumumab's potential in autoimmune disease is unaffected by its failure in lymphoma, Genmab said.

The failure comes on the heels of a major regulatory victory for Genmab after the Johnson & Johnson ($JNJ)-partnered daratumumab picked up FDA clearance for multiple myeloma last week. That treatment, to be marketed as Darzalex, won approval four months ahead of schedule, putting Genmab in line for an early glimpse at the milestone payments promised through its $1.1 billion licensing deal with J&J.

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