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The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts
At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At…
Shots:
The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy
Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…
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Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing
Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…

