AbbVie pushes confirmatory lung cancer trial for Emrelis nine months
The Phase 3 TeliMET NSCLC-01 trial's primary completion date slipped to December 2028 as AbbVie raised enrollment to 768, extending the timeline for confirming the accelerated approval behind Emrelis.
Executive Summary
- AbbVie's Phase 3 confirmatory trial for telisotuzumab vedotin in previously treated non-squamous NSCLC pushed its primary completion date out and simultaneously raised its enrollment target, extending the runway to the trial's survival readout.
- This is the trial that must confirm the overall-survival benefit behind an accelerated approval already granted to the drug, so a slower timeline delays when that approval can convert to full status.
- The completion date has now shifted five times since the trial began, a pattern of repeated slippage rather than a single one-off delay.
- The trial is the only Phase 3 asset targeting c-Met in this specific lung cancer population, so its outcome carries limited direct readthrough to other sponsors' programs, even as it anchors the drug's own path to full approval.
The change
AbbVie's registry update for NCT04928846, the TeliMET NSCLC-01 trial, moved the primary completion date to December 1, 2028, from March 1, 2028, a nine-month extension disclosed on July 16, 2026. The same update raised the trial's target enrollment from 698 to 768 patients. The trial compares intravenous telisotuzumab vedotin against docetaxel in adults with c-Met overexpressing, EGFR wild-type non-squamous NSCLC who progressed on prior therapy, testing overall survival and blinded independent central review progression-free survival as co-primary endpoints over a follow-up window of roughly 39 months. NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)NCT04928846
A recurring pattern
This is the fifth time the primary completion date has changed since the trial's 2021 registration: it moved from March 2027 to June 2025 in 2022, then out to March 2028 in 2024, then to March 1, 2028 in December 2024, and now to December 1, 2028. Enrollment has also grown twice, from 600 to 698 patients in 2021 and now to 768. The trial remains open and recruiting across the United States, China and Japan, and it started dosing patients in March 2022. NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)NCT04928846
What the trial confirms
Telisotuzumab vedotin, sold as Emrelis, already holds accelerated approval for locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression in patients who received prior systemic therapy, based on response rate and duration of response. That accelerated approval carries a requirement for confirmatory evidence, and TeliMET NSCLC-01, testing the drug head-to-head against docetaxel with overall survival as a primary endpoint, is that confirmatory study. A longer enrollment and completion window pushes out when AbbVie can bring survival data forward to convert the approval to full status. NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)NCT04928846
The competitive field
Within c-Met-targeted therapy in non-squamous NSCLC specifically, this is the only Phase 3 trial recorded, with the closest same-target, same-modality peer, Chong Kun Dang Pharmaceutical's CKD-703, still in Phase 1/2 testing across tumors. AbbVie is also running a separate Phase 2/3 trial of a newer c-Met-directed antibody-drug conjugate, telisotuzumab adizutecan, in combination with osimertinib in EGFR-mutated NSCLC, a different population and combination than this trial's monotherapy comparison against docetaxel. The broader c-Met target field remains active across NSCLC, with 76 trials recorded against the target, but almost none contest this specific line-of-therapy and comparator design.
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