OnCo
trialsTrialPositive

IND.227 / KEYNOTE-483

Showed that adding a PD-1 blocker to standard chemotherapy helps in mesothelioma, giving a second immunotherapy-based first-line option.

OS 17.3 vs 16.1 months (HR 0.79); ORR 52% vs 29%. Benefit again concentrated in non-epithelioid disease. FDA approval 17 September 2024 for pembrolizumab with pemetrexed and platinum. An academic-led trial (CCTG) with industry drug supply.

Setting
Unresectable pleural mesothelioma, first line: pembrolizumab + platinum-pemetrexed vs platinum-pemetrexed
Phase
Phase 3
Sponsor
Canadian Cancer Trials Group / Merck
Registry
Headline result
OS 17.3 vs 16.1 months, HR 0.79; ORR 52% vs 29%.
Reported
2023
Enrolled
440
Replication
Supported by DREAM (phase 2, durvalumab + chemotherapy) but DREAM3R phase 3 was stopped early; BEAT-meso (atezolizumab + bevacizumab + chemotherapy) missed OS.

Outcomes

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In plain words
What these results mean for people, not percentages
440 people took part
Overall survivalprimarysurvival endpoint
  • Median 17.3 vs 16.1 months with Pembrolizumab + chemotherapy compared with Chemotherapy; about 1.2 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 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.64 to 0.98).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Objective response rateresponse endpoint
  • 52 vs 29 out of 100 had their tumour shrink with Pembrolizumab + chemotherapy compared with Chemotherapy; 23 more per 100.
  • Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Be careful
  • These results apply to the people the trial enrolled: Unresectable pleural mesothelioma, first line: pembrolizumab + platinum-pemetrexed vs platinum-pemetrexed. 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.

440 participants enrolled.

Overall survivalprimary
HR 0.79 (0.64–0.98) · p = 0.0324
Pembrolizumab + chemotherapy
17.3 mo
Chemotherapy
16.1 mo
Source
Objective response rate
Pembrolizumab + chemotherapy52 of 100
Chemotherapy29 of 100
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryPembrolizumab + chemotherapy22217.3 months0.79 (0.64–0.98)0.0324link
Chemotherapy21816.1 months
Objective response ratePembrolizumab + chemotherapy52%
Chemotherapy29%
Replication
Supported by DREAM (phase 2, durvalumab + chemotherapy) but DREAM3R phase 3 was stopped early; BEAT-meso (atezolizumab + bevacizumab + chemotherapy) missed OS.

Connected

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