The Nail in the Coffin?: Examining the KEYNOTE-789 Clinical Trial’s Impact

Figures & data

Table 1 Efficacy and Safety of IO + Chemotherapy for EGFR Mutated NSCLC in Clinical Trials

Trial Name	Orient-31	Impower-150	Checkmate-722	Keynote-789
Phase	3	3	3	3
Sample	474	Total 1202, 124 (EGFR subgroup)	294	492
Sites	China	Global	Global	Global
Design	A: sintilimab+ IBI305+ pemetrexed+ cisplatin (N= 158) B: sintilimab + chemo (N= 156) C: chemo alone (N= 160)	A: atezolizumab+ BCP (bevacizumab+ carboplatin+ paclitaxel) (EGFR N= 34/ 400) B: atezolizumab+ carboplatin +paclitaxel (EGFR N= 45/ 402) C: BCP (EGFR N =45/ 400)	A: nivolumab+platinum-doublet chemo (N= 144) B: platinum-doublet chemo (N= 150)	A: pembrolizumab+ pemetrexed+platinum (N= 245) B: pemetrexed+ Platinum (N= 247)
Stratification factors	Sex, brain mets	Sex, liver mets, PDL1 expression	PDL1 <1% vs ≥1%, brain mets, smoking history, prior osimertinib use	PDL1 <50% vs ≥50%, prior use, East Asia vs not East Asia
ORR	A: 48.1% B: 34.8% C: 29.4%	A: 70.6% B: 35.6% C: 41.9% (EGFR subgroup)	A: 31% B: 27%	A: 29% B: 27.1%
DOR (months)	A: 8.5 B: 7.4 C: 5.7	A: 11.1 B: 5.6 C: 4.7 (EGFR subgroup)	A: 6.7 B: 5.6	A: 6.3 B: 5.6
PFS (months)	A: 7.2 B: 5.5 C: 4.3	A: 10.2 B: 6.9 C: 6.9 (EGFR subgroup)	A: 5.6 B: 5.4	A: 5.6 B: 5.5
OS (months)	A: 21.1 B: 20.5 C: 19.2	A: Not estimable B: 21.4 C: 18.7 (EGFR subgroup)	A: 19.4 B: 15.9	A: 15.9 B: 14.7
Grade 3–4 AE Rate	A: 51.9% B: 40.4% C: 48.8%	A: 64% B: 68% C: 64% (EGFR subgroup)	A: 45% B: 29%	A: 53.9% B: 53.2%
Death Rate	A: 3.8% B: 0.6% C: 0.6%	A: 0 B: 0 C: 2% (EGFR subgroup)	A: 1% B: 1%	A: 2% B: 4.9%

Abbreviations: AE, adverse effect; DOR, duration of response; IO, immunotherapy; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.