In a first, MorphoSys, Incyte win Monjuvi FDA nod in lymphoma to challenge Roche’s Polivy

Stamp with blue ink that says "FDA Approved"
MorphoSys and Incyte’s Monjuvi, used in combination with Celgene’s Revlimid, has won the first-ever FDA nod in second-line treatment of relapsed or refractory diffuse large B-cell lymphoma. (Olivier Le Moal/Getty Images)

The FDA hasn’t specifically approved a therapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after an initial line of therapy—until now.

MorphoSys and Incyte’s Monjuvi—also known as tafasitamab—in combination with Celgene’s Revlimid now represents the first FDA-approved second-line regimen for DLBCL, the two companies said Friday.

Because of Monjuvi’s importance as a new option in treating DLBCL, MorphoSys and Incyte will launch the drug soon despite COVID-19 restrictions. The med will roll out at an average wholesale acquisition cost of $16,500 per month in the first year of treatment and $13,000 per month after that, MorphoSys chief commercial officer Roland Wandeler told investors during a conference call on Monday.

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The two companies will have “mirrored” commercial and medical teams throughout the U.S., Incyte’s North America chief Barry Flannelly said on the call. They intend to focus their 150-person sales and marketing team on 11,000 key prescribers, which have 80% overlap with Incyte’s Jakafi, he said. By MorphoSys’ estimate, about 10,000 new U.S. patients will be eligible for Monjuvi in the second-line or later-line settings of DLBCL treatment.

Monjuvi targets the same CD19 antigen as Novartis’ Kymriah and Gilead Sciences’ Yescarta—two CAR-T therapies that are both cleared as third-line treatments for certain types of large B-cell lymphoma. But Monjuvi’s “long duration of response offers CAR-T-like efficacy, and without the significant safety side effects and major administration challenges associated with CAR-T therapy,” SVB Leerink analyst Geoffrey Porges wrote in a Monday note to clients.

RELATED: Incyte pays $750M upfront for rights to MorphoSys cancer drug

The FDA based the go-ahead on cancer shrinkage data from the phase 2 L-MIND study. In the trial, the Monjuvi-Revlimid combo triggered a response in 55% of patients—including 37% who saw no signs of cancer—at some point during the study period, defined as best objective response rate. 

By comparison, Roche’s CD79b-targeting antibody-drug conjugate Polivy, in its own clinical trial, showed a BOR rate of 63% and eliminated cancer in 50% of patients. It would be problematic to draw direct comparisons of data between different trials but industry watchers constantly do it anyway.

Monjuvi’s discontinuation rate of 15% fares favorably against the 31% from the Polivy trial, Porges noted.

“We believe [Monjuvi] will most likely be preferred over Polivy for the R/R DLBCL population,” Porges said. He called the second-line label the “best-case scenario” for Monjuvi, as Polivy only bears approval in the third-line setting despite having enrolled a similar patient population with both second-line and third-line cases.

MorphoSys is also running the phase 2/3 B-MIND trial, pitting Monjuvi against Roche’s Rituxan in their respective combinations with Teva's Treanda; Rituxan is the backbone of the standard-of-care R-CHOP regimen for non-Hodgkin lymphoma. And to convert the current accelerated FDA green light into a full one, MorphoSys plans to launch a confirmatory phase 3 trial in first-line DLBCL next year.

Editor's Note: The story has been updated to reflect that Monjuvi's 55% response rate was BOR, not ORR. And Polivy's comparator data have been changed accordingly.

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