June 13, 2017
By Alex Keown, BioSpace.com Breaking News Staff
KENILWORTH, N.J. – Merck & Co. has halted two Phase III multiple myeloma trials testing its blockbuster anti-PD-1 drug Keytruda after an external monitoring committee expressed concern over trial patient deaths in the groups taking the Merck drug.
On Monday, Merck said the two trials, Keynote-183 and Keynote-185, will resume after they fully understand why there were more patient deaths in the Keytruda groups. Patients in the two groups will continue to receive treatment while the trials are halted. Merck said its other Keytruda trials have not been affected. Keytruda is involved in almost 500 clinical trials in more than 30 cancers and treatment settings.
Share prices of Merck fell slightly on Monday, down about 1.4 percent, although the prices are rising this morning. The two trials, Keynote-183 and Keynote-185, were testing Keytruda in combination with two Celgene drugs, Revlimid and Pomalyst. Keynote-183 is a Phase III study comparing pomalidomide (Pomalyst) and low-dose dexamethasone with KEYTRUDA to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least two lines of prior treatment.
Multiple myeloma is a blood cancer that affects the bone marrow.
Keynote-185 is a Phase III study comparing lenalidomide and low-dose dexamethasone with Keytruda to lenalidomide (Revlimid) and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (Auto-SCT).
Keytruda is a keystone drug for Merck. The PD-1 inhibitor has been approved to treat multiple types of cancer, including lung, bladder, melanoma and refractory classical Hodgkin lymphoma. In May, the U.S. Food and Drug Administration expanded Keytruda’s use by approving it for two new bladder cancer options. It was approved as a first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Keytruda was also approved as a second-line treatment in locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Keytruda, as well as other PD-1 inhibitors such as Bristol-Myers Squibb ’s Opdivo, fight cancers by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which activates the body’s T-cells.
BMS’ Opdivo, as well as Genentech ’s PD-1 inhibitor Tecentriq, have seen their share of troubles. Most recently Tecentriq flunked a Phase III bladder cancer trial and last year Opdivo failed to meet its endpoints in a Phase III trial as a monotherapy for a “broad patient population” in lung cancer.
There are currently five anti-PD-1 drugs on the market. In addition to Keytruda, Tecentriq and Opdivo, AstraZeneca has Imfinzi on the market. In May, Merck KgaA and Pfizer saw approval for Bavencio.
