Bio-Thera raises BAT3306 biosimilar trial enrollment to 160 in NSCLC
The Phase 1 study testing whether BAT3306 matches Keytruda's pharmacokinetics in resected lung cancer grew its target enrollment by 20 patients, a routine adjustment ahead of a 2027 completion date.
Executive Summary
- Bio-Thera Solutions widened the enrollment target for a Phase 1 trial comparing its proposed pembrolizumab biosimilar against Keytruda in resected non-small cell lung cancer, an adjustment that sits within the routine range for a study still recruiting toward its 2027 completion.
- The trial exists to establish pharmacokinetic equivalence, the threshold a biosimilar must clear before it can be positioned as a lower-cost substitute for an approved checkpoint inhibitor.
- Bio-Thera's earlier, larger Phase 3 attempt to bring BAT3306 into this same indication was terminated, making the current smaller pharmacokinetic study the active vehicle for the program.
- The PD-1 checkpoint-inhibitor field in NSCLC is dense with direct comparators already in Phase 3, so BAT3306's near-term value rests on replicating Keytruda's established pharmacokinetic and safety profile rather than differentiating on efficacy.
The change
Bio-Thera Solutions (Bio-Thera) increased the anticipated enrollment for NCT07180862 from 140 to 160 participants, according to the trial's clinicaltrials.gov update history. The trial, registered as a Phase 1 study, is randomized, double-blind, and designed to test whether BAT3306 matches the pharmacokinetics of US-licensed Keytruda (pembrolizumab) when given as adjuvant therapy (post-surgery) to patients with completely resected NSCLC who have no EGFR mutation or ALK rearrangement. Enrollment began under a Not-Yet-Recruiting status in September 2025 and moved to Recruiting in January 2026. NCT07180862+1A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer ParticipantsNCT07180862A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer ParticipantsJul 17, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial measures
The primary endpoint is pharmacokinetic equivalence, specifically the area under the concentration curve at steady state (AUC0-tau,ss), measured across the first treatment cycle. Secondary endpoints include immunogenicity (anti-drug antibody rates), adverse events graded by CTCAE v5.0, and an exploratory comparison of disease-free survival between the two arms. Participants receive 200 mg by intravenous infusion every three weeks for up to 12 months, with serum sampled repeatedly across the first year to build the equivalence case. No results have been posted to the registry. NCT07180862A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer ParticipantsNCT07180862
Reading the enrollment move
The 140-to-160 increase amounts to a 14% jump, below the 20% threshold the operational risk model uses to flag a significant enrollment change, and Phase 1 increases are excluded from that model's alert criteria altogether. The trial's broader protocol history shows one status change and one enrollment change since first posting, a pace the registry-churn proxy labels stable. Nothing in the amendment history touched the primary endpoint, the primary completion date, or the eligibility criteria in a way that altered what the trial tests. NCT07180862A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer ParticipantsNCT07180862
A prior attempt ended early
Bio-Thera previously ran a larger, Phase 3 trial of BAT3306 against Keytruda in metastatic non-squamous NSCLC, enrolling 162 patients before that study was terminated. That leaves the current Phase 1 pharmacokinetic study as the company's active vehicle for establishing BAT3306's biosimilarity case in lung cancer. Across its broader portfolio, Bio-Thera has completed 31 of 38 trials with a track record and terminated 7, and it has completed 80% of five prior lung-cancer trials.
The competitive field
PD-1-targeted development in NSCLC is active: ten trials share BAT3306's target and mechanism class as direct comparators, including Merck's own pembrolizumab program (NCT06623422), which is running a Phase 3 disease-free-survival study in the same resected, adjuvant NSCLC setting with a stated completion in 2033. Pembrolizumab is approved in NSCLC, so BAT3306's task is not to beat that established profile but to reproduce it: the trial's read-through value depends on whether its pharmacokinetic and immunogenicity data land inside the equivalence margins that regulators require of a biosimilar, not on showing superiority.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.