OnCo
trialsTrialPositive

CheckMate 648

Showed two immunotherapy options for squamous oesophageal cancer, including one with no chemotherapy at all, both extending survival.

PD-L1 ≥1%: OS 15.4 vs 9.1 months with nivolumab + chemotherapy (HR 0.54) and 13.7 vs 9.1 months with nivolumab + ipilimumab (HR 0.64) (NEJM 2022). All randomised: HR 0.74 and 0.78. Five-year follow-up (2026) confirms durable benefit. FDA approval May 2022 for both regimens.

Setting
First-line advanced oesophageal squamous cell carcinoma: nivolumab + chemotherapy, or nivolumab + ipilimumab (chemotherapy-free), vs chemotherapy
Phase
Phase 3
Sponsor
BMS
Registry
Headline result
PD-L1 ≥1%: OS 15.4 vs 9.1 months (nivo + chemo, HR 0.54); 13.7 vs 9.1 months (nivo + ipi, HR 0.64).
Reported
2021
Enrolled
970
Replication
Consistent with KEYNOTE-590 and RATIONALE-306; the chemotherapy-free doublet is unique to this trial.

Outcomes

2top
In plain words
What these results mean for people, not percentages
970 people took part
Overall survival, PD-L1 ≥1% (nivolumab + chemotherapy)primarysurvival endpoint
  • Median 15.4 vs 9.1 months with Nivolumab + chemotherapy compared with Chemotherapy; about 6.3 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).
Overall survival, PD-L1 ≥1% (nivolumab + ipilimumab)survival endpoint
  • Median 13.7 vs 9.1 months with Nivolumab + ipilimumab compared with Chemotherapy; about 4.6 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 36 percent lower chance of the event at any given time (hazard ratio 0.64).
Be careful
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • These results apply to the people the trial enrolled: First-line advanced oesophageal squamous cell carcinoma: nivolumab + chemotherapy, or nivolumab + ipilimumab (chemotherapy-free), vs chemotherapy. 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.

970 participants enrolled.

Overall survival, PD-L1 ≥1% (nivolumab + chemotherapy)primary
HR 0.54
Nivolumab + chemotherapy
15.4 mo
Chemotherapy
9.1 mo
Source
Overall survival, PD-L1 ≥1% (nivolumab + ipilimumab)
HR 0.64
Nivolumab + ipilimumab
13.7 mo
Chemotherapy
9.1 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survival, PD-L1 ≥1% (nivolumab + chemotherapy)primaryNivolumab + chemotherapy15.4 months0.54link
Chemotherapy9.1 months
Overall survival, PD-L1 ≥1% (nivolumab + ipilimumab)Nivolumab + ipilimumab13.7 months0.64link
Chemotherapy9.1 months
Replication
Consistent with KEYNOTE-590 and RATIONALE-306; the chemotherapy-free doublet is unique to this trial.

Connected

5top