New trial data has set up a US filing later this year for MorphoSys’ anti-CD19 antibody tafasitamab (MOR208) – and a possible challenge to Novartis and Gilead’s CAR-T therapies.
The phase 2 L-MIND study in diffuse large B-cell lymphoma (DLBCL) showed that the combination of tafasitamab with Celgene’s Revlimid (lenalidomide) had an overall response rate of 60%, with 43% complete responses indicating the disease had disappeared entirely.
The results are impressive, particularly as the 80 patients enrolled in the L-MIND trial would typically be considered unsuitable for the approved CAR-T therapies for DLBCL, Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel).
The median progression free survival (mPFS) was 12.1 months with a median follow-up of 17.3 months, and the medium duration of response (mDoR) was 21.7 months, backing up earlier clinical results reported at the American Society of Haematology (ASH) meeting last December which were described as the lead investigator as “remarkable.”
MorphoSys has said it hopes to file tafasitamab with the FDA before the end of this year, setting up a possible launch in mid-2020 of what could be the German biotech’s first commercial product.
The solid results with the antibody are likely to cause some nervousness among the CD19-targeting CAR-T players, as the data suggests that the tafasitamab regimen might be able to offer efficacy approaching that of cell therapy, without the cumbersome and often-debilitating regimen of harvesting cells, re-engineering them and then reinfusing them into the patient.
The data suggests that new antibody could eventually also mount a challenge to Roche’s CD38-targeting Rituxan (rituximab) – also approved as a therapy for DLBCL but facing biosimilar competition – as well as Roche’s CD79b-targeting antibody-drug conjugate (ADC) polatuzumab vedotin, that has already been filed in the US.
MorphoSys is also carrying out a second phase 2 trial, called B-MIND, looking at tafasitamab plus bendamustine versus Rituxan plus bendamustine in patients with relapsed/refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation. Results from the trial are due later this year.
A third trial, called COSMOS, is spearheading tafasitamab’s move into other blood cancers. It is looking at the safety of the antibody in combination of Gilead’s Zydelig (idelalisib) or Roche/AbbVie’s Venclexta (venetoclax) in patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have failed or become intolerant to prior treatment with Johnson & Johnson’s Imbruvica (ibrutinib).
The L-MIND data raise the likelihood of MorphoSys attracting a commercial partner for the antibody, which has been tipped as a $1bn-plus product by analysts.