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PAPILLON's 34.3-month survival missed the unadjusted test; 76 percent later switched

IASLC's final PAPILLON overall-survival analysis reports 34.3 months with first-line amivantamab plus chemotherapy versus 27.9 months with chemotherapy alone; HR 0.87 and P 0.307 missed the statistical threshold. Clinical Trial Vanguard repeats that unadjusted miss and the 76 percent later switch, plus a prespecified adjusted HR 0.57 that is nominal.

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34.3 versus 27.9 months, P 0.307

The final overall survival analysis of the phase III PAPILLON trial in advanced lung cancer with EGFR exon 20 insertions reports a median of 34.3 months with first-line amivantamab plus chemotherapy against 27.9 months with chemotherapy alone; with a hazard ratio of 0.87 and P 0.307, the difference did not cross the statistical threshold. Of 128 chemotherapy-arm participants who stopped at progression, 97 (76 percent) went on to second-line amivantamab. A prespecified inverse-probability weighting model brings the hazard ratio to 0.57 (nominal P 0.003); that adjusted analysis is nominal and exploratory. Median follow-up was 48.6 months with a data cutoff of 20 March 2026. The results were presented at the World Conference on Lung Cancer in Seoul.[1]

Vanguard treats the later switch as part of the result

Moe Alsumidaie writes that the protocol-specified PAPILLON overall-survival comparison returned HR 0.87 and missed significance, while 76 percent of eligible chemotherapy-arm patients later received amivantamab. A prespecified crossover-adjusted analysis cut the risk of death by 43 percent (HR 0.57; nominal p=0.003). Median overall survival was 34.3 months with the combination versus 27.9 months with chemotherapy. The piece treats the 76 percent later switch as part of the result, not a footnote.[2]

Unadjusted miss, adjusted exploratory

IASLC and Clinical Trial Vanguard agree that unadjusted overall survival missed at HR 0.87, that 76 percent later received amivantamab, and that a prespecified adjusted HR 0.57 is nominal. 34.3 versus 27.9 months is the shared median pair. The adjusted P 0.003 is nominal, not the protocol-specified test.[1], [2]

References

  1. News sourceIASLCPAPILLON: amivantamab with chemotherapy gives 34.3-month median survival, but the gap misses statistical significance↩1↩2
  2. News sourceClinical Trial VanguardPAPILLON's unadjusted survival test missed significance after 76 percent crossover↩1↩2
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