Genmab/J&J’s Phase Ib subQ Darzalex for myeloma needs definitive noninferiority vs approved IV formulation to justify pursuit – experts

08 Sep 2016

Genmab (CPH:GEN) and Johnson & Johnson’s (NYSE:JNJ) Phase Ib trial of subcutaneous Darzalex (daratumumab) for multiple myeloma (MM) will need to demonstrate noninferior efficacy and toxicity to the intravenous (IV) formulation to bolster its development and market rationale, experts said.

The convenient shorter injection time will unlikely make up for any diminished efficacy or increased toxicity, an investigator explained. However, he and others said there are already early signs of tolerability that may be better than IV Darzalex’s, which could boost its competitive edge.

If the subQ version was approved based on noninferiority, its main competition would come from IV-administered fellow CD38-targeting monoclonal antibodies (mAbs) in Phase I/II development, namely Sanofi’s (EPA:SAN) isatuximab and MorphoSys’ (ETR:MOR) MOR202, as well as Celgene’s (NASDAQ:CELG) approved immunomodulator Pomalyst (pomalidomide), some experts said.

Darzalex’s peak MM sales are expected to reach USD 2.9bn in 2025, according to BioPharm Insight data, while isatuximab’s peak 2023 sales are expected to reach USD 471m. Peak sales for MOR202 are expected to reach EUR 500m in 2036, according to an analyst report.

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