Monjuvi takes on a first in second-line treatment

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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
Polivy Roche CD79B ADC 200 1,309 3L
Lisocabtagene Maraleucel
(Liso-cel)
Bristol-Myers Squibb CD19 Car-T  5 1,151 Filed in 3L
Kymriah Novartis CD19 Car-T  434* 1,149* 3L
Monjuvi
(tafasitamab)
MorphoSys/Incyte CD19 MAb 46 687 2L
*Sales not split by indication, source: EvaluatePharma

 

Tafasitamab studies in selected DLBCL studies
Study Design Detail Result
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.

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