MorphoSys eyes MOR208 approval after midphase DLBCL data impress

MorphoSys CEO Simon Moroney (MorphoSys)

MorphoSys is hoping to hustle MOR208 through an early, speedy regulatory filing after posting an upbeat look at phase 2 data. Median progression-free survival (PFS) is still ticking up in the trial of the CD19 monoclonal antibody, adding weight to MorphoSys’ claims MOR208 can hold its own against CAR-T therapies. 

Investigators in the relapsed or refractory diffuse large B cell lymphoma (DLBCL) trial have enrolled all of the planned 81 participants and had efficacy data on 68 of them as of the most recent cutoff.

When treated with MOR208 and Celgene’s Revlimid, almost half of the participants responded, with 31% of them experiencing complete responses. Having followed the patients for an average of 8.3 months, the trial is yet to reach the preliminary median PFS. The preliminary, 12-month PFS rate is 50%. Two-fifths of subjects—and almost 90% of responders—were yet to progress as of the cutoff date. 

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To put those figures in context, a pooled analysis of two phase 2 Revlimid monotherapy studies reported overall and complete response rates of 26% and 9%, respectively, in patients with relapsed or refractory DLBCL. Median PFS in the larger of the two trials clocked in at 2.7 months. MOR208 has already bettered that and the figure is still rising.

If MOR208 comes to market it will have to prove itself against more recently developed drugs than Revlimid, though. Gilead’s Kite and Novartis have both aimed their CAR-T drugs at DLBCL, chalking up overall and complete response rates as high as 82% and 49%. But MorphoSys thinks the rate at which the proportion of responders in those trials dropped off in the following months means MOR208 has an edge, even before factoring in safety and logistics.

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MorphoSys will need durability data to make a truly compelling case as the longer-running CAR-T trials suggest patients on those drugs who are in remission after six months stay in remission. But with MorphoSys’ data pointing in the right direction, the German biotech is talking to the FDA about the possibility of filing for approval based on the midphase data. 

Successfully executing that plan would mark a big moment for MorphoSys, which has stepped up its investment in internal R&D in recent years to push programs toward the finish line. After seeing one of its partnered programs, Johnson & Johnson’s Tremfya, win approval for the first time last year, MorphoSys could now follow up with its inaugural in-house regulatory nod.