Genmab A/S, and Johnson & Johnson’s Janssen division have pulled the plug on the Phase Ib/II trial of daratumumab in combination with Roche’s Tecentriq.
Genmab A/S, based in Copenhagen, Denmark, and U.S.-based Johnson & Johnson’s Janssen division have pulled the plug on the Phase Ib/II trial of daratumumab in combination with Roche’s Tecentriq (atezolizumab) in patients with advanced or metastatic non-small cell lung cancer.
The action followed a planned review by a Data Monitoring Committee (DMC). In addition, a Phase I MMY2036 trial of daratumumab plus JNJ-63723283, an anti-PD-1 antibody in multiple myeloma is being discontinued.
The committee decided there was no observed benefit in the combination treatment arm, daratumumab with atezolizumab over atezolizumab alone. The DMC also observed a numerical increase in mortality-related events in the combination arm.
In the trial, CALLISTO/LUC2001, daratumumab in combination with atezolizumab was being compared to atezolizumab monotherapy alone. Genma granted Janssen the exclusive worldwide license to develop, manufacture and commercialize daratumumab in August 2012.
“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 Jan van de Winkel, Genmab’s chief executive officer, in a statement. “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.”
Genmab shares dropped as much as 25 percent in early trading as a result of the announcement.
Reuters noted, “The potential to use Darzalex, a key treatment in multiple myeloma, in solid tumors was eagerly awaited and some analysts had seen the outcome of the study as this year’s biggest price trigger for the stock.”
“Investors should not hope for a further adventure for Darzalex in solid tumors,” Soren Lontoft, an analyst with Sydback wrote, reported Reuters.
Daratumumab is marketed under the trade name Darzalex. It is dosed as an intravenous infusion. In the U.S., it is prescribed in combination with bortezomib, melphalan and prednisone to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. It is also indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat MM in patients who have received at least one prior therapy, in combination with pomalidomide and dexamethasone to treat MM patients who have received at least two previous therapies, including lenalidomide and a proteasome inhibitor. It is also indicated as a monotherapy for patients with MM who have received at least three previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
MorphoSys, a primary competitor in the space, is suing both companies, alleging that daratumumab infringes on the company’s patent for a drug targeting the same antigen. The trial is scheduled for August in the state of Delaware. Last year, GenMab and J&J also discontinued developing daratumumab for non-Hodgkin’s lymphoma after it did not improve patient health in a Phase II clinical trial.
However, in a Phase III trial wrapped up last year, daratumumab with chemotherapy cut the progression of MM and deaths from the disease by 50 percent compared to chemotherapy on its own.
