This site is intended for health professionals only
Sunday 16 June 2019
Share |

Janssen stops Darzalex/Tecentriq combo trial

Based on a recent planned review, the Data Monitoring Committee (DMC) recommends termination of Phase Ib/II study of daratumumab plus atezolizumab (anti PD-L1 antibody) in patients with previously treated non-small cell lung cancer

A mid-stage trial involving patients with pre-treated metastatic non-small cell lung cancer has been terminated after a combination of daratumumab (Janssen’s Darzalex) and atezolizumab (Roche’s Tecentriq) failed to show any benefit over the latter alone.
International biotechnology company Genmab said a data monitoring committee (DMC) recommended that the Phase Ib/II study (CALLISTO/LUC2001) being run by partner Janssen should be terminated. The DMC concluded that there was no observed benefit within the combination treatment arm [May 26 2018]. The DMC also noted a numerical increase in mortality-related events in the combination arm.
In addition, the phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma will be discontinued.
Janssen has informed health authorities about these events and has contacted its partner companies conducting daratumumab and anti-PD-(L)1 combination studies to discuss ceasing enrollment and dosing of the combination while the data is being further investigated.
Jan van de Winkel, chief executive officer of Genmab, said: "While we are disappointed that the studies will be discontinued, Genmab fully supports Janssen's decision as patient safety is paramount in drug development. We look forward to gaining a better understanding of the data upon further analysis.
“We are pleased that the development program for daratumumab remains expansive and continues to benefit patients with Multiple Myeloma."
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.

Ads by Google

You are leaving

You are currently leaving the Nursing in Practice site. Are you sure you want to proceed?


Respect for nurses: Sign up to our e-petition TODAY

The Nursing in Practice Respect campaign is now live! Over the coming months, we're set to highlight the vital contribution and efforts of primary care and community care nurses throughout the UK.

As part of our campaign, Nursing in Practice is looking to call on parliament to set up a debate to celebrate the vital work that you do.



Calling all primary care nurses! 'Like' our Nursing in Practice Facebook page to enter our free draw to win a £25 M&S voucher