The EMA has started its review of MorphoSys’ anti-CD19 antibody tafasitamab (MOR208), setting up a possible challenge to Novartis and Gilead’s CAR-T therapies if approved.
The US regulator accepted MorphoSus and partner Incyte’s marketing application for tafasitamab for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) – including DLBCL arising from low grade lymphoma – in adults who are not candidates for a stem cell transplant.
The review is based on the phase 2 L-MIND study, which showed that tafasitamab given with Celgene’s Revlimid (lenalidomide) – followed by tafasitamab on its own – achieved an overall response rate of 60%, including 43% complete responses indicating the disease had disappeared entirely.
The study was conducted in patients who would be considered too frail to undergo treatment with the approved CD19-targeting CAR-Ts for DLBCL, Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel).
CAR-T therapy requires the use of high-dose chemotherapy to clear the path for modified T cells that are directed to attack the cancer, and some patients – particularly the elderly – are not physically strong enough to tolerate the treatment.
The start of the EMA’s review follows shortly after the FDA started the clock ticking on a biologics license application (BLA) for tafasitamab in the US earlier this year, setting up a verdict by 30 August.
Incyte bought into the programme in January, paying a sizeable $750m upfront for rights to the drug as well as making a $150m equity investment in MorphoSys. In the US the two countries will share eco-promotion rights and profits, while Incyte has exclusive rights elsewhere.
MorphoSys is also eligible to receive milestone payments worth up to $1.1bn, in addition to any royalties from the drug, which has previously been tipped as a $1bn-plus product by analysts at SVB Leerink.
DLBCL is the most common type of non-Hodgkin’s lymphoma (NHL) in adults worldwide accounting for 40% of all cases, and is a very aggressive disease – around 30-40% of patients do not respond to initial therapy or relapse, meaning there is a pressing need for new therapies.
Relapsed DLBCL isn’t expected to be a big indication for the drug in commercial terms, but Incyte is taking a gamble that tafasitamab will also prove effective in the First-MIND study in previously-untreated DLBCL – a much bigger market – as well as a head-to-head comparison with rituximab in relapsed DLBCL patients (B-MIND).
MorphoSys has also been studying the drug in other indications like other forms of NHL such as follicular lymphoma (FL) and marginal zone lymphoma (MZL), and chronic lymphocytic leukaemia (CLL).
The drug is viewed as an important addition to Incyte’s pipeline, which has suffered setbacks including the failure of its phase 3 candidate itacitinib in first-line, acute graft vs host disease.