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KEYNOTE-564

The first drug to help kidney cancer patients live longer after surgery, and the first adjuvant immunotherapy in any solid tumour to show an overall survival gain.

DFS HR 0.72; OS HR 0.62 at 57 months (91.2% vs 86.0% alive); 5-year OS 87.7% vs 82.3% (HR 0.66). FDA approval November 2021. Three other adjuvant IO trials (IMmotion010, CheckMate 914, PROSPER) were negative, making KEYNOTE-564 an outlier that LITESPARK-022 has now built on.

Setting
Clear-cell RCC at intermediate-high or high risk of recurrence after nephrectomy (or M1 NED): adjuvant pembrolizumab 1 year vs placebo
Phase
Phase 3
Sponsor
Merck
Registry
NCT03142334
Headline result
DFS HR 0.72; OS HR 0.62.
Reported
2021
Enrolled
994
Replication
Not replicated by atezolizumab (IMmotion010), nivolumab ± ipilimumab (CheckMate 914), or perioperative nivolumab (PROSPER); LITESPARK-022 (pembrolizumab ± belzutifan) is positive on DFS.

Outcomes

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In plain words
What these results mean for people, not percentages
994 people took part
Disease-free survivalprimarysurrogate endpoint
  • The treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • 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.
Overall survival (57-month follow-up)survival endpoint
  • 91.2 vs 86 out of 100 alive with Pembrolizumab compared with Placebo; 5.2 more per 100.
  • Roughly one extra person helped for every 19 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.44 to 0.87).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Clear-cell RCC at intermediate-high or high risk of recurrence after nephrectomy (or M1 NED): adjuvant pembrolizumab 1 year vs placebo. 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.

994 participants enrolled.

Disease-free survivalprimary
HR 0.72 (0.59–0.87)

Numbers not yet public.

Source
Overall survival (57-month follow-up)
HR 0.62 (0.44–0.87) · p = 0.002
Pembrolizumab
91.2 mo
Placebo
86 mo
Source
EndpointArmnValueHR (95% CI)pSource
Disease-free survivalprimaryPembrolizumab496—0.72 (0.59–0.87)—link
Placebo498—
Overall survival (57-month follow-up)Pembrolizumab—91.2 % alive0.62 (0.44–0.87)0.002link
Placebo—86 % alive
Replication
Not replicated by atezolizumab (IMmotion010), nivolumab ± ipilimumab (CheckMate 914), or perioperative nivolumab (PROSPER); LITESPARK-022 (pembrolizumab ± belzutifan) is positive on DFS.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Renal cell carcinoma

drugs

1
ApprovedMonoclonal antibody (anti-PD-1)
Pembrolizumab · Keytruda / Keytruda Qlex (SC)

terms

1
Neoadjuvant / adjuvant / perioperative

ideas

1
Biomarker-selected adjuvant therapy in RCC (ctDNA, CAIX PET, gene signatures)

people

1
Toni K. Choueiri