Second-line avelumab treatment of patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from a global expanded access program (EAP).
Bibliographic record
Abstract
9537 Background: Avelumab is a human anti–PD-L1 IgG1 antibody that showed a favorable efficacy and toxicity profile in pts with mMCC and progressive disease (PD) on or after chemotherapy (CT) in the phase 2 JAVELIN Merkel 200 trial (JM 200; NCT02155647), leading to accelerated approval in the US and Europe. We describe real-world experience with avelumab in a global EAP for pts with mMCC. Methods: Pts participating in the EAP (NCT03089658) had stage IV mMCC and PD on or after CT or were ineligible for CT. In contrast to JM 200, pts in the EAP could have ECOG performance status of 2, treated brain metastases, or immunosuppressive conditions with sponsor medical approval. Pts received avelumab 10 mg/kg IV Q2W until PD or unacceptable toxicity. A 3-mo supply of avelumab for approved pts was provided to treating physicians; additional re-supply was allowed for pts who had complete response (CR), partial response (PR), stable disease (SD), or clinical benefit per treating physician assessment. No central imaging was obtained. Results: Between Jan 2016 and Jan 2018, 460 requests for avelumab were received from 37 countries: 395 were approved, 45 were medically rejected for various reasons (eg, incorrect diagnosis, lack of appropriate prior therapy, incomplete information), and 37 were withdrawn. Most requests were from France (n = 97), Italy (n = 69), and Australia (n = 46). Median age was 74 y (range, 28-95), and 65.7% of pts were male. Among 131 response-evaluable pts, the objective response rate was 51.1%, including CR in 22.1% (n = 29) and PR in 29.0% (n = 38; including 1 pt with HIV); 19.1% (n = 25) had SD and 29.8% (n = 39) had PD. Durable responses were observed in immune-competent and immunosuppressed pts. Updated data will be presented. The safety profile was similar to that of JM 200. The EAP is ongoing but will close in 2018 (US closed in April 2017) with regulatory approval in multiple countries. Conclusions: The avelumab EAP rapidly enrolled many pts with mMCC and answered an unmet, urgent medical need for pts ineligible for clinical trials or for whom no approved alternative treatments were available. In a real-world setting, avelumab demonstrated safety and efficacy consistent with JM 200. Clinical trial information: NCT03089658.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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 teacher head, 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".