Incyte blood cancer drug combo reduces disease-progression risk but with high side-effect rate

Analysts and investors are anxious for more side effect and discontinuation data from the intensive multi-drug therapy

Incyte's Monjuvi as part of a multi-drug regimen that includes a chemotherapy standard of care for an aggressive form of non-Hodgkin lymphoma reduced the risk of disease progression, relapse or death by 25% compared to the standard alone, but with a higher rate of study dropouts due to side effects.

The company, which first announced the data in January, said it would have overall survival data for the drug combination at a later date. Pablo Cagnoni, Incyte's research chief, said the survival analysis was "early" but showed a clear trend toward improvement.

The trial tested a combination of Monjuvi, Bristol Myers Squibb's blood cancer drug Revlimid and R-CHOP - a standard multi-chemotherapy regimen - against R-CHOP alone, in some 900 patients with newly diagnosed diffuse large B-cell lymphoma, or DLBCL, the most common type of non-Hodgkin lymphoma.

Analysts and investors were anxious for more side effect and discontinuation data from the intensive multi-drug therapy.

Severe adverse events were more common for those who received the Monjuvi combo at nearly 87 percent versus 76 percent of patients who just got R-CHOP, which involves five medicines.

Discontinuations due to treatment-related adverse events were also higher at 25.7 percent compared with 18 percent for standard care. Deaths listed as due to adverse events were 6 percent in the Incyte drug group, compared with 3.8 percent for standard care.

The overall death rate, however, was lower for the Incyte/ Bristol Myers/R-CHOP combination at 18.5 percent compared to 21.7 percent for R-CHOP.

"Sometimes when you add another drug, you obviously see a little bit more side effects, which is why it's so important to report the survival data, because all of this gets integrated into survival," said Incyte's Cagnoni.

The detailed results were presented at the American Society of Clinical Oncology meeting in Chicago.

Cagnoni said more than 50 percent of the high-risk patient population that still receives R-CHOP as treatment could be eligible for the new regimen as a first-line, or initial, therapy as soon as it gets approval.

About 18,000 to 25,000 people in the US are diagnosed with the disease each year, according to government data.

Monjuvi, known chemically as tafasitamab, received accelerated US approval in combination with Revlimid for patients whose disease has returned or did not respond to earlier treatment, and those who are not eligible for stem cell transplant.

Cagnoni said the company plans to seek expanded approval in the U.S. and Europe for the combo therapy as an initial treatment for newly diagnosed patients.

"This doubles the potential eligible population," Cagnoni said.