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HengRui challenges with a Polivy follow-on

Remarkably, there are just three anti-CD79b antibody-drug conjugates in clinical development in addition to Roche's Polivy, and one of them just went into phase 3. That project is Jiangsu HengRui's SHR-A1912, and its just revealed pivotal study, in second-line diffuse large B-cell lymphoma, has been launched on the back of just one dataset, from a phase 1 trial presented at last year's ASCO conference. Those data, in the relapsed/refractory setting, showed a 59% ORR among 27 patients with diffuse large B-cell lymphoma, and 61% in those with all B-cell non-Hodgkin's lymphomas, including 11 with follicular and three with marginal-zone lymphoma. There was an 18% rate of liver enzyme elevation, but none at grade 3 or above, and the poster's authors noted that a 3.6mg/kg dose of SHR-A1912 produced a 100% ORR in DLBCL. In November 2023 HengRui started a phase 1/2 trial including first-line patients, but its new phase 3 study concerns the relapsed/refractory DLBCL setting; primary endpoints in the pivotal study are response rate and overall survival. The only other clinical-stage anti-CD79b ADCs, according to OncologyPipeline, are Polivy, AbbVie's ABBV-291 and NBT508, a phase 1 molecule in development by China's NewBio Therapeutics.



Clinical-stage anti-CD79b ADCs

ProjectCompanyPayloadStatus
PolivyRocheMMAE, auristatinApproved as R-CHP combo in 1st-line large B-cell lymphoma; 
Approved as Rituxan + bendamustine combo in 3rd-line+ B-cell lymphoma
SHR-A1912Jiangsu HengRuiTopo1 inhibitorPh3 R-GemOx combo, vs R-GemOx, in r/r diffuse large B-cell lymphoma
NBT508NewBio TherapeuticsMMAE, auristatinPh1 in r/r B-cell non-Hodgkin’s lymphoma
ABBV-291AbbVieTopo1 inhibitorPh1 in r/r B-cell non-Hodgkin's lymphoma

Source: OncologyPipeline.

Tags

Molecular Drug Targets