CAPTAIN-1st
CAPTAIN-1st showed that adding the PD-1 antibody camrelizumab to gemcitabine and cisplatin kept advanced nasopharyngeal cancer under control for about three months longer, confirming with a second drug what JUPITER-02 found with toripalimab.
Overview
CAPTAIN-1st randomised 263 patients with untreated recurrent or metastatic nasopharyngeal carcinoma at 28 Chinese centres to camrelizumab or placebo with gemcitabine and cisplatin for up to six cycles, followed by camrelizumab or placebo maintenance. Gemcitabine-cisplatin had been the standard since the 2016 GEM20110714 trial.
Reported by Yunpeng Yang and Li Zhang in Lancet Oncology in 2021, median progression-free survival was 9.7 months with camrelizumab against 6.9 months with placebo (hazard ratio 0.54). Camrelizumab's characteristic reactive capillary haemangiomas were the main additional toxicity.
With JUPITER-02 (toripalimab) and RATIONALE-309 (tislelizumab), it made PD-1 blockade with gemcitabine-cisplatin the first-line standard for advanced nasopharyngeal carcinoma in China and in the NCCN guideline; camrelizumab was approved for this use in China in 2021.
- Median 9.7 vs 6.9 months with Camrelizumab + gemcitabine-cisplatin compared with Placebo + gemcitabine-cisplatin; about 2.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Untreated recurrent or metastatic nasopharyngeal carcinoma: camrelizumab or placebo with gemcitabine and cisplatin, then camrelizumab or placebo maintenance. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
263 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Camrelizumab + gemcitabine-cisplatin | - | 9.7 months | 0.54 | - | - |
| Placebo + gemcitabine-cisplatin | - | 6.9 months |
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