Like many developers of cancer drugs, MorphoSys AG is using data from a single-arm Phase 2 trial as the basis for a regulatory submission to the US Food and Drug Administration. The company’s L-MIND trial reported positive results in May showing that the antibody tafasitamab, combined with the myeloma drug lenalidomide, met its primary endpoint of objective response in patients with lymphoma. This is the basis of a rolling submission to the FDA.
Recently, this clinical data was backed up with information from a real world study of lenalidomide alone. This study confirmed the objective response rate from L-MIND while providing additional, positive data on complete response and overall survival. MorphoSys, along with other developers, has been experimenting with synthetic, or real-world studies, in order to supplement the findings of their single-arm studies. In this instance, the initiative worked.
“We are confident that the regulatory package is very robust and that we will finish the submission by the end of the year,” Jean-Paul Kress, MorphoSys’s new chief executive, told analysts in a teleconference on 30 October.
Tafasitamab is an Fc-engineered antibody directed against the cancer antigen CD19 which has been developed for patients with refractory diffuse large B cell lymphoma (DLBCL) who have had up to two prior medical treatments and are not eligible for high-dose chemotherapy or autologous stem cell transplantation. In the L-MIND study, these patients had a median progression-free survival of 12.1 months at a median 17.3 month follow-up, indicating that a high proportion experienced a long-term treatment effect.
Tafasitamab is being targeted at the US market and preparations for commercialisaion started more than a year ago. In February, the company hired David Trexler from EMD Serono to lead the marketing effort.
In the analysts’ call, Dr Kress said MorphoSys is sufficiently resourced, pending regulatory approval, to make a solo launch, but it is also looking for partnering opportunities. Potential revenue from tafasitamab would complement royalty income the company already receives from Tremfya, an antibody therapeutic for plaque psoriasis developed by Janssen Biotech Inc using MorphoSys’ technology.
In the third quarter, MorphoSys reported revenue of €12.5 million, down from €55 million a year earlier, when it received €47.5 million from Novartis under a licensing deal. Higher spending on R&D led to a rise in operating expenses and a loss before interest and taxes of €27 million compared with earnings of €30.1 million a year earlier. Cash at the end of the quarter was €412.4 million. Owing to higher than expected Tremfya royalties, MorphoSys expects revenue this year to be at the upper end of the €65 to €72 million range.
Looking ahead, MorphoSys plans to develop tafasitamab as a first-line treatment for DLBCL in combination with chemotherapy. It is also planning to study MOR202, a CD38-directed antibody, in membranous nephropathy. On the downside, a trial of a MorphoSys antibody for atopic dermatitis conducted with Galapagos NV and Novartis, was stopped for futility on 28 October 2019.
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