BioPharma

MorphoSys builds out U.S. infrastructure for anticipated launch of lymphoma drug

The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.

A German biotech company plans to go it alone in the U.S. commercialization of a drug for lymphoma, and to that end has hired more than one-quarter of the people it plans to employ at its local office, its CEO said.

In an interview Tuesday, MorphoSys CEO Simon Moroney said the Munich-based company had hired 20 of a planned 90 employees for its location in Boston, intended as the base for its launch of the drug tafasitamab, in diffuse large B-cell lymphoma. On the other hand, he said the company would probably partner the drug outside the U.S. Moroney will step down as CEO in September, replaced by Jean-Paul Kress, the company said Monday.

Tafasitamab, also known as MOR208, is a monoclonal antibody directed at the antigen CD19 that the company is developing for DLBCL, in combination with Celgene’s Revlimid (lenalidomide). Moroney noted the company is on track to submit a regulatory approval application to the Food and Drug Administration by the end of this year.

The company will seek approval based on the Phase II L-MIND study of 81 patients. Data from the study presented Saturday at the International Conference on Malignant Lymphoma in Lugano, Switzerland, showed a 60 percent overall response rate, including a 43 percent complete response rate. Median duration of response was 21.7 months, while median progression-free survival – notwithstanding the trial being a single-arm study – was 12.1 months. The median overall survival was not reached, but the 12-month OS rate was 73.3 percent.

“This is data that’s as good as we’ve seen in this setting,” Moroney said. “We’re optimistic about the chances of the product and think it offers an attractive new option.”

Assuming the FDA considers those data sufficient for approval, Moroney said it is unclear whether tafasitamab will receive an accelerated approval or a full-approval. In the event of an accelerated approval, he said the company would potentially use the Phase III B-MIND trial – testing MOR208 in combination with Roche’s Rituxan (rituximab) and bendamustine – as the confirmatory trial. There is, however, precedent for a full approval, namely the FDA approvals of CD19-directed CAR-T cell therapies, based on single-arm trial data, Moroney noted.

For the time being, MorphoSys’ submission package will include a synthetic control arm of real-world data from patients previously treated with Revlimid, for which Moroney said the company has the FDA’s blessing. The data are being collected with the help of an undisclosed contract research organization, and the company needs data from around 80 patients whose baseline characteristics are similar to those of patients in L-MIND. Revlimid is not approved for treating DLBCL, so that means the data would be for patients who received it off-label. It is unclear if an approval for MOR208 would also result in a DLBCL indication for the Celgene drug, Moroney said.

At least initially, however, MOR208 is not designed to compete with CAR-Ts, given that it is being developed among older patients who are unfit for stem cell transplant, and thus unfit for CAR-T therapy. But while the company does not yet have data on the rate of patients whose disease relapses without the CD19 antigen – which would presumably make them ineligible for CAR-T therapy – Moroney noted that there was one patient who received tafasitamab and, following treatment with the drug, went on to receive CAR-T and achieved a complete remission, suggesting there was no antigen-negative relapse.

Photo: MorphoSys

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