Prodotti competitors / Area Oncology
Pfizer registers new P1/2 trial of maplirpacept + glofitamab in 2L+ r/r DLBCL
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On June 9th, 2023, Pfizer registered a new, multicenter, open-label P1/2 trial (PCD: Jun 2026) assessing the safety, tolerability, and clinical benefits of maplirpacept (TTI-622; SIRPα-Fc IgG4) + glofitamab (COLUMVI; CD20 x CD3 bsAb) + obinutuzumab (GAZYVA; CD20 mAb) in 2L+ r/r DLBCL.
Key Details and Implications:
- The newly posted trial is in line with Pfizer previously stated plan that maplirpacept (TTI-622) could be a “potential backbone combinatorial agent for heme malignancies”
- The company has previoulsy highlighted their focus on prioritizing combinations with “expected SOC agents” (PFE EC Q1 2022)
- Other ongoing trial of interest are: P1/2 trial (PCD: Nov 2025) evaluating maplirpacept + tafasitamab (MONJUVI; CD19 mAb) + lenalidomide (REVLIMID; IMiD) in r/r DLBCL , a P1b trial (PCD: Aug 2025) of maplirpacept + elranatamab (BCMA x CD3 bsAb) in r/r MM, and a P1China-only trial (PCD: Aug 2024) assessing the safety of maplirpacept (TTI-622; SIRPα-Fc IgG4) monotherapy in r/r NHL and MM patients
- Glofitamab is expected to be the second bsAb to enter the r/r DLBCL market with US approval expected in Q3 2023 (PDUFA action date Jul 1st, 2023) and EU approval anticipated in 2023 (CHMP recommended conditional approval in Apr 2023)
- Recently presented data from extended follow-up of the pivotal P2 study of glofitamab + obinutuzumab in r/r LBCL showed continued durable responses, with an estimated 70% of patients with a CR remaining in remission at 18mo, and a manageable safety profile (ASCO, #7550)
- It is expected to face signficant in-class competition in the crowded CD20 x CD3 bispecific space as epcoritamab (EPKINLY; CD20 x CD3 DuoBody) was recently approved by the FDA in 3L+ r/r DLBCL and Regeneron’s odronextamab (CD20 x CD3 bsAb) BLA submissionis anticipated in H2 2023 for treatment of r/r DLBCL
- Bispecifics are expected to become the standard of care in the r/r DLBCL treatment algorithm, as an off-the-shelf treatment option for patients ineligible for SCT and unable to receive and/or refractory CAR-T; combinations with novel agents of varying MoAs have been explored to potentially boost efficacy and improve outcomes
- As the priortized asset of Pfizer's long term heme pipeline strategy, maplirpacept is expected to be a key in-class competitor to magrolimab as its development ramps up, however, its current development overall still lags behind that of magrolimab and is likley not a near term threat
- Data from these early bispecific studies can also serve as POC for novel future magrolimab combinations as well
- Maplirpacept also has the advantage of having access to Pfizer's current heme / oncology portfolio to explore possible combinations across multiple indications
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