Pfizer, MorphoSys and Incyte Take Aim at DLBCL in New Collab
MorphoSys U.S. Inc., a subsidiary of MorphoSys AG, announced a clinical trial collaboration and supply agreement with Pfizer and Incyte. The arrangement will test Pfizer’s TTI-622 in conjunction with Monjuvi (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
‟This collaboration has the potential to advance patient care in an area where there continues to be significant unmet medical need,” Lance Leopold, M.D., group vice president of clinical development, hematology and oncology at Incyte said. “We are proud to support this research effort to evaluate the potential of a new chemotherapy-free combination for these patients.”
Monjuvi is a CD19-directed immunotherapy drug. It is a product co-commercialized by MorphySys and Incyte. The two companies made the agreement official in January 2020 in a $1.1 billion deal to develop Monjuvi and commercialize it worldwide. In August 2020, the U.S. Food and Drug Administration approved Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. This was the FDA’s first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.
Now the companies are hoping to achieve even greater results by adding TTI-622 to the mix. TTI-622 is a novel SIRPα-Fc fusion protein that blocks the signal-regulatory protein (SIRP)α–CD47 axis, a key checkpoint that has shown promise in helping regulate hematological cancers. Patients who have solid and hematological malignancies, including DLBCL, who also have a high CD47 expression tend to have poorer prognoses.
Currently, TTI-622 is in Phase Ib/II development. The drug is being tested across several indications, particularly in hematological cancers.
At the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in 2020, MorphoSys presented preclinical data showing a strong synergy of Monjuvi and anti-CD47 antibodies in in vitro and in vivo lymphoma models. The fact that TTI-622 also affects CD47 would appear to make it a perfect match.
“The early results for TTI-622 in late-line advanced lymphoid malignancies reflect the potential for class-leading monotherapy activity, and preclinical evidence with a diverse set of therapeutic agents provide a strong rationale for testing combination therapies. We are pleased to collaborate with MorphoSys and Incyte, generating additional evidence on the potential of TTI-622 to improve outcomes for patients with DLBCL,” Chris Boshoff, M.D., Ph.D., chief development officer, oncology, Pfizer Global Product Development said.
Pfizer said it will initiate a multicenter, international Phase Ib/II study of TTI-622 with Monjuvi and lenalidomide for patients with relapsed or refractory DLBCL who are not eligible for ASCT. MorphoSys and Incyte will provide Monjuvi for the study, which will be sponsored and funded by Pfizer. The companies plan to conduct studies in North America, Europe and the Asia-Pacific areas.
‟Monjuvi in combination with lenalidomide is an important treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma, and its mechanism of action, efficacy and safety profile make it an attractive combination partner,” Malte Peters, M.D., MorphoSys chief research and development officer said. “We believe that the addition of novel immunotherapies, such as the investigational anti-CD47 blocking agent TTI-622, to the backbone of Monjuvi plus lenalidomide, have the potential to provide new meaningful combination treatment options for patients with relapsed or refractory diffuse large B-cell lymphoma.”
If approved, the combination of drugs could be lucrative for all three companies involved. According to a market research report by InsightAce Analytic, the immuno-oncology market is projected to hit $34.69 billion by 2030.