Keynote-365 cohort C: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC).
Bibliographic record
Abstract
171 Background: Pembro has antitumor activity as monotherapy in pretreated advanced mCRPC (KEYNOTE-028; KEYNOTE-199). A study has suggested that pembro + enza after progression on enza may have clinical activity. KEYNOTE-365 (NCT02861573) is a phase 1b/2 umbrella study testing combinations in mCRPC; we report early results from cohort C combining pembro + enza in mCRPC. Methods: Patients who failed or became intolerant to ≥4 weeks of abi in the pre-chemotherapy mCRPC state were included. Pts also had to have progressed within 6 months prior to screening as determined by either PSA progression or radiologic progression in bone or soft tissue. Pts received pembro 200 mg intravenously Q3W with enza 160 mg per day orally, and response was evaluated by PSA levels Q3W and imaging Q9W for the first year and Q12W thereafter. Primary end points were safety and PSA response rate (confirmed PSA decline ≥50%). Key secondary end points were investigator-assessed ORR (RECIST v1.1), disease control rate (DCR: CR+PR+SD ≥6 mo), time to PSA progression, rPFS, and OS. Results: 69 pts initiated treatment (median age 69 years; PD-L1+ 30%; visceral disease 26%; measurable disease 36%). Median (95% CI) follow-up was 9 (7-13) mo. See efficacy outcomes in table. Treatment-related AEs occurred in 63 (91%) pts; most frequent (≥20%) were fatigue (30%), rash (23%), and nausea (22%). Grade 3-4 treatment-related AEs occurred in 28 (41%) pts; no deaths were due to treatment-related AEs. Conclusions: Early results from the pembro + enza combination show sustained activity in abi-pretreated frontline mCRPC. Observed safety profile for the combination treatment was consistent with the known safety profiles of pembro and enza. Clinical trial information: NCT02861573. [Table: see text]
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".