MorphoSys, Incyte Get Early FDA Nod for Antibody Alternative to CAR-T

Xconomy Europe — 

A MorphoSys antibody drug developed for diffuse large B-cell lymphoma (DLBCL) has won FDA approval, providing an alternative to cumbersome and risky CAR-T therapies to treat the cancer.

The late Friday approval for the drug, tafasitamab (Monjuvi), covers adults whose DLBCL has relapsed or has not responded to an earlier treatment. MorphoSys (NASDAQ: MOR), a company based in Germany, will co-commercialize the drug in the US with Wilmington, DE-based Incyte (NASDAQ: INCY) under a partnership signed earlier this year.

DLBCL is the most common form of non-Hodgkin lymphoma. It involves rapidly growing masses of cancerous B-cells in the lymph nodes, spleen, liver, bone marrow, or other organs. The first line of treatment is typically rituximab (Rituxan) and chemotherapy. If those treatments don’t work, high doses of chemo and a stem cell transplant are recommended next. Not all patients qualify for stem cell transplants, and those who are eligible face risks from the procedure. Approval of the MorphoSys drug gives those patients a new second-line treatment option.

The MorphoSys drug is an antibody designed to home in on CD19, a protein found in abundance on cancerous B cells. It’s the same protein targeted by CAR-T therapies, which are approved for patients whose DLBCL has not responded to two earlier lines of treatment. CAR-T immunotherapies are made by harvesting a patient’s immune cells, engineering them to better recognize and fight the cancer, multiplying those cells in a lab, and then infusing them back into the patient.

The process for making a CAR-T therapy takes time, and the approved treatments from Novartis (NYSE: NVS) and Gilead Sciences (NASDAQ: GILD) also pose safety risks. Black boxes on the drugs’ labels warning that treatment can cause an immune response called cytokine release syndrome as well as toxic effects on the brain.

FDA approval of tafasitamab is based on an open-label Phase 2 study enrolling 81 patients who received the MorophoSys antibody and the Bristol Myers Squibb (NYSE: BMY) cancer drug lenalidomide (Revlimid). The main goal of the study was to show efficacy according to the overall response rate, defined as the percentage of patients who showed a complete or partial response to the therapy. The study also assessed the duration of the response.

The results showed a 55 percent overall response rate, including a complete response—a disappearance of the signs of the cancer—in 37 percent of patients. The median duration of the response to treatment was 21.7 months. The most common side effects reported in the study included an abnormally low level of white blood cells, fatigue, anemia, diarrhea, an abnormally low level of platelets, cough, fever, swelling, respiratory tract infection, and a decreased appetite.

The duration of the MorphoSys therapy’s effect gives it “CAR-T like efficacy, and without the significant safety side effects and major administration challenges associated with CAR-T therapy,” analysts at SVB Leerink wrote in a research note. As an antibody, the MorphoSys drug offers an alternative to other types of DLBCL treatments. The biggest question was whether the FDA would approve it as a second line of therapy or as a third, the SVB Leerink analysts wrote.

Roche antibody drug conjugate polatuzumab vedotin (Polivy) was tested in patients similar to those evaluated in the MorphoSys clinical trial. But the FDA’s 2019 decision for the Roche drug in DLBCL approved it only as a third line of treatment. As a second line of therapy, tafasitamab has a “great competitive advantage” compared to other late-line treatments for DLBCL, the SVB Leerink analysts wrote.

Speaking on a Monday conference call, MorphoSys Chief Operating Officer Roland Wandeler said tafasitamab will carry an average wholesale price of $16,500 per month, or $198,000 for the first year of therapy. In the second year of treatment, the drug’s average wholesale price will drop to $13,000 per month, which Wandeler attributed to fewer doses required per treatment cycle. That puts the average price for two years of treatment at $354,000. By comparision, the CAR-T therapies from Gilead and Novartis are priced at $373,000 for the one-time therapies. MorphoSys estimates that 10,000 US patients with DLBCL are eligible for second-line treatment with tafasitamab under the labeling the FDA approved for the drug.

Tafasitamab is currently under review in Europe and MorphoSys expects to receive a decision in 2021. The FDA approval comes a few weeks earlier than the Aug. 30 target date for a regulatory decision. It was made on an accelerated basis, meaning the agency reviewed a thinner body of evidence than is typically required. That means MorphoSys will need to provide additional clinical data in order to retain the drug’s approval.

MorphoSys executives said a Phase 3 study for tafasitamab is already underway. The company plans to start a study next year to support use of the drug as a first-line DLBCL treatment.

Image: iStock/rightdx

 

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