Dive Brief:
- In a setback for Danish drugmaker Genmab, topline results from a Phase 3 study showed combining the company's drug Arzerra with bendamustine did not improve progression-free survival in indolent non-Hodgkin lymphoma (NHL) compared to bendamustine alone.
- Arzerra is marketed under a collaboration agreement between Genmab and Novartis, and is approved for chronic lymphocytic leukemia in the U.S. and Europe. The Phase 3 study testing the drug in NHL was sponsored by Novartis.
- A subcutaneous formulation of Arzerra is also under investigation in two Phase 3 clinical studies in relapsing multiple sclerosis. These trials of Arzerra are not affected by the NHL results, Genmab said.
Dive Insight:
Genmab has sought new indications for Arzerra (ofatumumab), its first marketed product, as the drug is facing increasing competition in the chronic lymphocytic leukemia (CLL) market.
In light of this competition, Genmab's marketing partner Novartis already has pulled Arzerra from markets outside the U.S. except for compassionate use.
Net sales of Arzerra recorded by Novartis were $36 million in 2017, down 22% from $46 million in the year prior. Genmab's royalty income on net sales of Arzerra was DKK48 million (approximately $7.5 million) in 2017 compared with DKK63 million (approximately $9.9 million) in 2016.
"We are disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial," said Jan van de Winkel, CEO, Genmab said in a statement. "The full data will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result."
It's not clear, however, whether development of Arzerra will continue in NHL.
Genmab has already faced setbacks in Arzerra in NHL and Jefferies equity analyst Peter Welford had only projected $150 million in peak sales.
Elsewhere, in relapsing multiple sclerosis (RMS), recruitment has completed in two Phase 3 trials of a subcutaneous formulation of Arzerra in comparison with teriflunomide. Phase 2 results from the MIRROR study showed the treatment reduced the number of new lesions 12 weeks after starting treatment in people with relapsing multiple sclerosis.
RMS is a competitive field, however, with blockbuster incumbents and a full pipeline of drugs advancing toward market. After some delays, Celgene expects to refile ozanimod for approval in the first quarter of 2019. Merck KGaA's evobrutinib has positive results in Phase 2. TG Therapeutics' ublituximab expects to move into Phase 3 in 2019. And Biogen has picked up Alkermes' ALKS 8700, which is in Phase 3 for relapsing MS.