Co-formulated favezelimab plus pembrolizumab versus standard-of-care in previously treated, PD-L1-positive metastatic colorectal cancer: The phase 3, randomized KEYFORM-007 study.
Bibliographic record
Abstract
LBA248 Background: Effective treatment options remain an unmet need for patients (pts) with microsatellite stable/mismatch repair proficient (MSS/pMMR) metastatic colorectal cancer (mCRC). Combination therapy with the anti–lymphocyte activation gene (LAG)-3 antibody favezelimab (fave) and the PD-1 inhibitor pembrolizumab (pembro), has shown promising antitumor activity and manageable safety in PD-L1 CPS ≥1 MSS/pMMR mCRC. The phase 3 KEYFORM-007 study (NCT05064059) evaluated the efficacy and safety of co-formulated fave/pembro vs standard-of-care (SOC) in PD-L1–positive MSS/pMMR mCRC. We present results of the pre-specified final analysis of OS. Methods: Eligible pts with PD-L1 CPS ≥1, MSS/pMMR unresectable mCRC (Stage IV per AJCC 8 th edition), who had progressed on or after, or could not tolerate standard treatment were randomized 1:1 to co-formulated fave 800 mg/pembro 200 mg IV Q3W (Arm A) or SOC (regorafenib 160 mg PO Q4W [QD on days 1-21] or TAS-102 35 mg/m 2 PO Q4W [BID on days 1-5 and 8-12]) (Arm B). Randomization was stratified by geographic region, presence or absence of liver metastases, and time from initial diagnosis of metastatic disease to randomization. Treatment continued for up to 35 cycles or until unacceptable toxicity, progression, confirmed CR (Arm A), or withdrawal. The primary endpoint was OS. The data cut-off was August 15, 2024. Secondary endpoints included PFS, ORR, and DOR (central review, RECIST v1.1 [assessed at interim analysis with data cut-off of August 21, 2023]), and safety. Results: At final analysis, 441 pts (63% male; 59% RAS mutant) were randomized (221 fave/pembro; 220 SOC. Median follow-up was 28 mo (range, 21-32). Median OS was not superior with fave/pembro vs SOC (median 7.3 vs 8.5 mo; HR 0.98; 95% CI, 0.80-1.20; P = 0.4183) in pts with MSS/pMMR mCRC. PFS was not superior with fave/pembro vs SOC (median 2.1 vs 2.6 mo; HR 1.34; 95% CI, 1.09-1.64; nominal P = 0.997). Per protocol, PFS was not tested for statistical significance. A confirmed objective response occurred in 15 (14PR; 1CR [6.8%]) vs 2 (2PR; [0.9%]) pts in the fave/pembro and SOC arms, with best response of PD occurring in 143 (65%) vs 94 (43%) pts, respectively. Median DOR was not reached ([NR] range, 1.8 to 16.8+) among the 15 responders in the fave/pembro arm, and was 6.5+ mo and 12.4 mo, for the 2 responders in the SOC arm. At final analysis, treatment-related adverse events (TRAEs) occurred in 145 (66%) vs 167 (80%) pts, respectively (grade ≥3 in 44 [20%] vs 76 [36%] pts). Adverse events of special interest occurred in 84 (38%) vs 13 (6%) pts, respectively. Conclusion: At final analysis, co-formulated fave/pembro did not improve OS vs SOC in pts with PD-L1-positive MSS/pMMR mCRC. The safety profile was manageable with no new safety signals observed. Clinical trial information: NCT05064059 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".