GEMSTONE-302
The trial behind sugemalimab's approval in China and later Europe, showing a PD-L1 antibody plus chemotherapy delays progression in both main types of lung cancer.
Overview
479 patients randomised 2:1. Median progression-free survival 7.8 versus 4.9 months (hazard ratio 0.50) at the interim analysis, with benefit in squamous and non-squamous histology and across PD-L1 levels; overall survival favoured sugemalimab at the final analysis. NMPA approval December 2021; European Commission approval July 2024, the first EU approval of a Chinese-developed PD-L1 antibody.
- Median 7.8 vs 4.9 months with Sugemalimab + chemotherapy compared with Placebo + chemotherapy; about 2.9 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 50 percent lower chance of the event at any given time (hazard ratio 0.5).
- 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: First-line metastatic squamous and non-squamous NSCLC without EGFR, ALK, ROS1 or RET alterations, China: sugemalimab or placebo plus platinum chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.
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.
Pages like this
not linked directly; found by shared links- TrialCameL
Shares Caicun Zhou, Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
- InstitutionChinese Thoracic Oncology Group
Shares Caicun Zhou, Non-small-cell lung cancer and the tag china.
- TrialORIENT-11
Shares Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
- InstitutionJiangsu Cancer Hospital
Shares Non-small-cell lung cancer and the tag china.
- TrialRATIONALE-302
Shares Immune checkpoint inhibitors and the tag china.
- ProductIcotinib
Shares Non-small-cell lung cancer and the tag china.
- ProductSintilimab
Shares Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
- ProductEnvafolimab
Shares Immune checkpoint inhibitors and the tag china.