Onco-Summaries: Daily Oncology Updates at a Glance

29/06/2026

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• Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial

• Samsung Bioepis’ Keytruda biosimilar SB27 demonstrates Phase 1 and Phase 3 equivalence in NSCLC trials

• MHRA validates Eisai and Nuvation Bio's taletrectinib MAA in UK, expanding ROS1+ NSCLC access

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Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial (Ref)

Genmab announced positive topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating epcoritamab (T-cell engaging bispecific antibody) combined with lenalidomide vs standard chemoimmunotherapy (R-GemOx) in relapsed/refractory DLBCL patients

• The trial met its primary objective, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 60% (US) and 56% (ex-US)

• Data will be submitted to regulators and presented at a future medical meeting

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Samsung Bioepis’ Keytruda biosimilar SB27 demonstrates Phase 1 and Phase 3 equivalence in NSCLC trials (Ref)

Samsung Bioepis reported positive preliminary results from Phase 1 and Phase 3 trials of SB27, a proposed biosimilar to Keytruda (pembrolizumab)

• SB27 has met primary endpoints in both Phase 1 and Phase 3 trials, showing equivalence to Keytruda in PK and efficacy, reinforcing Samsung Bioepis’s position in biosimilar development

Phase 1 trial:

• Randomized, double-blind, three-arm study in stage II–IIIA NSCLC patients following complete resection and adjuvant platinum-based chemotherapy

• Showed pharmacokinetic (PK) bioequivalence between SB27 and Keytruda (EU- and US-sourced)

• 163 participants; drug exposure (AUC) met predefined equivalence criteria

Phase 3 trial:

• Randomized, double-blind study in metastatic non-squamous NSCLC, followed by chemotherapy

• 555 participants; SB27 vs Keytruda followed by pemetrexed and carboplatin

• Objective response rate (ORR) at Week 24 was equivalent, with CI fully within predefined margins

• Safety, PK, and immunogenicity profiles were comparable

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MHRA validates Eisai and Nuvation Bio's taletrectinib MAA in UK, expanding ROS1+ NSCLC access (Ref)

The UK’s MHRA has validated the Marketing Authorisation Application (MAA) for taletrectinib (ROS1 inhibitor) in advanced ROS1+ NSCLC, submitted by Eisai under the International Recognition Procedure (IRP)

• Eisai holds rights across Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India

The EMA validated the MAA in March 2026; additional filings are planned for Canada and other Eisai territories

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II evaluating taletrectinib, in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)

• The long-term pooled results in TKI-naïve patients demonstrated a confirmed objective response rate (cORR) of 89.8%, a median duration of response (mDOR) of 49.7 months and a median progression-free survival (mPFS) of 46.1 months (Ref)

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