Incyte and Morphosys received the first approval in the US of a second-line treatment in relapsed or refractory diffuse large B-cell lymphoma (DLBLC), a major endorsement of the $750m Incyte paid upfront earlier this year for rights to Monjuvi, aka tafasitamab. The drug got the nod in combination with Revlimid on Friday, one month before its intended Pdufa date. The approval was based on the single arm L-Mind study, which enrolled both second and third-line patients, so a second-line label was the best outcome. Leerink analysts expect broad adoption in this setting due to “Car-T like efficacy, as well as Monjuvi’s favourable safety profile”. The analysts also expect the product to be preferred over Roche’s Polivy, which was approved last year but only managed a third-line label. Incyte and Morphosys are hoping to move Monjuvi up the treatment paradigm: a pivotal study in the first line setting is to start early next year.
|Selected DLBCL treatments (filed to marketed)|
|Annual indication sales ($m)|
|Product||Company||Mechanism of Action||2020||2026||Setting|
|Yescarta||Gilead Sciences||CD19 Car-T||536||1,332||3L|
|Bristol-Myers Squibb||CD19 Car-T||5||1,151||Filed in 3L|
|*Sales not split by indication, source: EvaluatePharma|
|Tafasitamab studies in selected DLBCL studies|
|L-mind||Tafasitamab + Revlimid combo, single-arm||81 r/r DLBCL subjects||Long term follow-up data: ORR 59%, CR rate 41%; median duration of response 34.6 months.
Accelerated FDA approval July 31
|Re-Mind||Revlimid monotherapy as "synthetic control"||490 r/r DLBCL subjects||Deemed positive on the basis of 76 subjects matched vs 80 in L-Mind|
|B-Mind||Tafasitamab + benda vs Rituxan + benda||450 r/r DLBCL subjects, measuring PFS in all-comers and biomarker defined||Passed futility analysis Nov 2019, recommendation to upsize from 330 subjects; topline data Q1 2022|
|First-Mind||Tafasitamab + Rituxan + CHOP; tafasitamab + Revlimid + Rituxan + CHOP||60 1st-line DLBCL subjects||Started late last year, primary completion date Nov 2020|
|Pivotal front line study||TBC||TBC 1st-line DLBCL subjects||To start early 2021|
|Source: clinicaltrials.gov & company disclosures.|