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Safety scuppers combo trials with J&J/Genmab’s Darzalex

Studies revealed a “numerical increase” in patient deaths when Darzalex was combined with Roche’s Tecentriq

J&J

Genmab’s hopes of finding a role for its Darzalex drug in combination with immuno-oncology drugs have hit a snag, with reports of increased mortality in trials pairing the antibody with checkpoint inhibitors.

A phase Ib/II trial of anti-CD38 antibody Darzalex (daratumumab) given in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in previously treated non-small cell lung cancer, and a phase I study pairing the drug with Johnson & Johnson’s experimental PD-1 inhibitor JNJ-63723283 in multiple myeloma, have both been terminated.

There was a “numerical increase” in deaths when Darzalex was added to Tecentriq and no evidence of any increase in clinical benefit compared to Tecentriq on its own in the LUC2001 trial, according to Genmab that prompted J&J - Genmab’s partner for Darzalex - to bring the myeloma trial (MMY2036) to a halt.

Shares in Genmab took a dive yesterday as news of the decision broke, and its also a big disappointment for J&J’s Janssen pharma unit which took a global license to Darzalex in 2012 in a deal valued at $1.1bn, ahead of its US approval as a myeloma therapy in 2015. Use of the drug in combination with cancer immunotherapies was a key component of Genmab and J&J’s plans to expand use of the drug beyond haematological malignancies and into solid tumours, which could dramatically increase its market size.

Darzalex is already a big earner for the two companies, bringing in $1.24bn in sales last year thanks to approval in five myeloma indications and a continued roll-out in new markets, but Genmab chief executive Jan van de Winkel has said the drug could eventually top $9bn in sales if its use could be expanded into other blood cancers and solid tumours.

“While we are disappointed that the studies will be discontinued, Genmab fully supports Janssen’s decision as patient safety is paramount in drug development,” said van de Winkel in a statement.

“We are pleased that the development program for daratumumab remains expansive and continues to benefit patients with multiple myeloma,” he added.

The company and J&J are working to advance Darzalex into front-line myeloma therapy, picking up approval in the US for use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) newly-diagnosed myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT) in the US last month. They are hoping for a positive verdict in Europe later this year.

Additional studies of Darzalex as an add-on to regimens based on Celgene’s Revlimid (lenalidomide) and in ASCT-eligible patients could further expand the opportunity in previously-untreated patients, says Genmab, and J&J is also carrying out mid-stage testing of Darzalex in ‘smouldering’ multiple myeloma, which is a precursor to full-blown disease.

Article by
Phil Taylor

29th May 2018

From: Research

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