Lung · NSCLC

In EGFR-mut subset PFS HR 0.48 (0.36-0.64); in EGFR-WT HR 2.85 (2.05-3.98); proved EGFR status is predictive

Population: East Asian never/light-smoker adenocarcinoma, clinically selected

mPFS 13.1 vs 4.6 mo, HR 0.16 (0.10-0.26); landmark for Chinese EGFR-TKI 1L

Population: Chinese advanced EGFR-mut NSCLC

mPFS 9.7 vs 5.2 mo, HR 0.37 (0.25-0.54); erlotinib 1L confirmed in Caucasian EGFR-mut

Population: European advanced EGFR-mut NSCLC

mPFS 11.1 vs 6.9 mo, HR 0.58 (0.43-0.78); bigger benefit in del19/L858R common mutations

Population: Advanced EGFR-mut lung adenocarcinoma, chemo-naive

mPFS 11.0 vs 5.6 mo, HR 0.28 (0.20-0.39); Asian afatinib 1L validation

Population: Asian EGFR-mut advanced NSCLC

mPFS 14.7 vs 9.2 mo, HR 0.59 (0.47-0.74); 2nd-gen TKI improves PFS over 1st-gen

Population: EGFR-mut advanced NSCLC, no brain mets

mPFS 10.1 vs 4.4 mo, HR 0.30 (0.23-0.41); established osimertinib for T790M resistance

Population: T790M+ NSCLC after 1st/2nd-gen TKI progression

mPFS 18.9 vs 10.2 mo, HR 0.46 (0.37-0.57); OS update mOS 38.6 vs 31.8 mo HR 0.80

Population: Advanced EGFR-mut (del19/L858R) NSCLC, chemo-naive

DFS HR 0.20 (0.14-0.30) in stage II-IIIA; OS HR 0.49 (0.33-0.73) in updated analysis

Population: Stage IB-IIIA completely resected EGFR-mut NSCLC

mPFS 25.5 vs 16.7 mo, HR 0.62 (0.49-0.79); TKI+chemo 可作为高危选项

Population: Advanced EGFR-mut NSCLC, chemo-naive

mPFS 11.4 vs 6.7 mo, HR 0.40 (0.30-0.53); first 1L for EGFR ex20

Population: EGFR exon 20 insertion advanced NSCLC 1L

mPFS 39.1 vs 5.6 mo, HR 0.16 (0.10-0.24); redefined SoC post-CRT in EGFR-mut III

Population: Unresectable stage III EGFR-mut NSCLC post-CRT

Teliso-V in c-MET high EGFR-WT non-squamous NSCLC: ORR 35% — basis for Emrelis accelerated approval.

Population: c-Met overexpressing EGFR-wildtype non-squamous NSCLC, ≤2 prior lines of therapy

mPFS 23.7 vs 16.6 mo, HR 0.70 (0.58-0.85); ami+laz superior to osi in PFS

Population: Advanced EGFR-mut (del19/L858R) NSCLC 1L

ami+chemo vs chemo PFS HR 0.48 (0.36-0.64); ami+laz+chemo HR 0.44 (0.35-0.56); established ami-based SoC after osi

Population: Post-osimertinib EGFR-mut NSCLC

ORR 72% (95% CI 58-84); mPFS 19.2 mo; mDOR 17.6 mo; 50 ROS1+ patients established crizotinib as ROS1+ NSCLC standard

Population: 50 patients with ROS1-rearranged advanced NSCLC (phase 1 expansion cohort)

mPFS 10.9 vs 7.0 mo, HR 0.45 (0.35-0.60); established crizotinib 1L for ALK+

Population: ALK-positive advanced non-sq NSCLC 1L

mPFS 34.8 vs 10.9 mo (updated), HR 0.43 (0.32-0.58); CNS progression HR 0.16

Population: ALK+ advanced NSCLC 1L

mPFS 16.6 vs 8.1 mo, HR 0.55 (0.42-0.73); confirmed 2nd-gen ALK TKI benefit

Population: ALK+ advanced NSCLC 1L

ORR 75% (61-85); histology-agnostic TRK inhibitor activity

Population: NTRK fusion+ tumors across histologies incl. NSCLC

mPFS NR vs 9.3 mo, HR 0.28 (0.19-0.41); intracranial response 82% vs 23%

Population: ALK+ advanced NSCLC 1L

Adjuvant alectinib in resected ALK+ NSCLC: DFS HR 0.24 vs chemo.

Population: completely resected ALK+ NSCLC, stage IB (≥4 cm) / II / IIIA, adjuvant setting

TKI-naive ORR 79% (68-88), mPFS 35.7 mo; TKI-pretreated ORR 38%; next-gen ROS1 covering G2032R

Population: ROS1+ NSCLC TKI-naive and pre-treated

ORR 42.9% (33.5-52.6); mPFS 6.5 mo; CNS penetration better than sotorasib

Population: KRAS G12C pre-treated NSCLC

mPFS 5.6 vs 4.5 mo, HR 0.66 (0.51-0.86); OS neutral; confirmatory RCT

Population: KRAS G12C NSCLC post-platinum+IO

Adagrasib vs docetaxel KRAS G12C NSCLC: mPFS 5.5 vs 3.8 mo, HR 0.58.

Population: KRAS G12C-mutant advanced NSCLC, previously treated with platinum chemo and anti-PD-(L)1

ORR 63.2% (49.3-75.6); mPFS 9.7 mo; established BRAF+MEK combo in NSCLC

Population: BRAF V600E pre-treated NSCLC

Pretreated ORR 64% (54-73); tx-naive ORR 85%; mDOR 17.5 mo

Population: RET fusion+ NSCLC

ORR 46% by liquid biopsy, 48% by tissue; mDOR ~11 mo; first MET-selective approval evidence

Population: MET exon 14 skipping NSCLC

Pretreated ORR 61% (50-71); tx-naive ORR 70%; another RET-selective TKI

Population: RET fusion+ NSCLC

ORR 55% (44-65); mDOR 9.3 mo; mPFS 8.2 mo; first HER2-targeted ADC efficacy in NSCLC

Population: HER2-mut pre-treated NSCLC

Final analysis — 5.4 mg/kg preferred dose, better tolerability with similar efficacy.

Population: previously platinum-treated HER2-mutant metastatic NSCLC

mPFS 24.8 vs 11.2 mo, HR 0.46 (0.31-0.70); RET-TKI 1L confirmed

Population: RET fusion+ advanced NSCLC 1L

Updated efficacy and safety of enco+bini in BRAF V600E NSCLC.

Population: BRAF V600E-mutant metastatic NSCLC (phase II, single-arm)

Oral HER2-selective TKI in HER2-mutated NSCLC: ORR 71%, mPFS 12.4 mo — FDA accelerated 2025.

Population: HER2-mutant advanced/metastatic NSCLC, previously treated (phase 1a-1b)

mOS 9.2 vs 6.0 mo, HR 0.59 (0.44-0.79); first PD-1 mAb approved in NSCLC

Population: Pretreated advanced squamous NSCLC

mOS 12.2 vs 9.4 mo, HR 0.73 (0.59-0.89); PD-L1 enrichment signal

Population: Pretreated advanced non-sq NSCLC

mOS pembro 2mg vs doc 10.4 vs 8.5 mo, HR 0.71 (0.58-0.88); PD-L1≥50% HR 0.54

Population: Pretreated PD-L1≥1% advanced NSCLC

mPFS 10.3 vs 6.0 mo, HR 0.50 (0.37-0.68); mOS 30.0 vs 14.2 mo

Population: PD-L1≥50% advanced NSCLC, chemo-naive

mOS 12.6 vs 9.7 mo, HR 0.73 (0.53-0.99); dose-response with PD-L1

Population: Pretreated advanced NSCLC

mPFS 16.8 vs 5.6 mo HR 0.52 (0.42-0.65); mOS 47.5 vs 29.1 mo HR 0.72

Population: Unresectable stage III NSCLC post-CRT

PD-L1≥1% mOS 17.1 vs 14.9 mo, HR 0.79 (0.67-0.94); dual-IO chemo-free option

Population: 1L advanced NSCLC all PD-L1

TPS≥50% mOS 20.0 vs 12.2 mo HR 0.69 (0.56-0.85); benefit driven by high expressors

Population: PD-L1≥1% advanced NSCLC 1L

TC3/IC3: mOS 20.2 vs 13.1 mo, HR 0.59 (0.40-0.89); atezolizumab 1L PD-L1-high

Population: PD-L1-high advanced NSCLC 1L

OS not significant (HR 0.76 not meeting threshold); bTMB signal; failed 1L IO-IO

Population: 1L metastatic NSCLC

ABCP vs BCP PFS HR 0.62 (0.52-0.74); mOS 19.2 vs 14.7 mo HR 0.78 (0.64-0.96)

Population: 1L non-sq NSCLC incl. EGFR/ALK after TKI failure

OS HR 0.49 (0.38-0.64); mOS 22.0 vs 10.7 mo; SoC for EGFR/ALK-WT 1L non-sq

Population: 1L advanced non-sq NSCLC without EGFR/ALK alterations

mOS 15.9 vs 11.3 mo, HR 0.64 (0.49-0.85); SoC for 1L squamous NSCLC

Population: 1L advanced squamous NSCLC

mOS 18.6 vs 13.9 mo, HR 0.79 (0.64-0.98); 1L non-sq IO-chemo option

Population: 1L non-sq NSCLC, EGFR/ALK-WT ITT

mPFS 8.9 vs 5.0 mo, HR 0.482 (0.362-0.643); Chinese-developed PD-1 1L data

Population: Chinese 1L non-sq NSCLC EGFR/ALK-WT

mPFS 11.3 vs 8.3 mo, HR 0.60 (0.45-0.79); camrelizumab 1L non-sq

Population: Chinese 1L non-sq NSCLC

mOS 15.6 vs 10.9 mo, HR 0.66 (0.55-0.80); limited-course chemo + dual IO

Population: 1L advanced NSCLC

PFS HR 0.60 (0.49-0.72); OS HR 0.86 (0.71-1.06) NS; positive PFS, negative OS

Population: 1L non-sq NSCLC EGFR/ALK-WT

mPFS 5.5 vs 4.9 mo, HR 0.536 (0.422-0.681); sintilimab 1L sq

Population: Chinese 1L sq NSCLC

mPFS 9.7 vs 7.6 mo, HR 0.645 (0.462-0.902); tislelizumab 1L non-sq

Population: Chinese 1L non-sq NSCLC

mPFS 7.6 vs 5.5 mo, HR 0.524 (0.370-0.742); tislelizumab 1L sq

Population: Chinese 1L sq NSCLC

durva+treme+chemo vs chemo mOS 14.0 vs 11.7 mo HR 0.77 (0.65-0.92); durva+chemo OS HR 0.86

Population: 1L metastatic NSCLC

MPR 83%, pCR 63% in resected; 24-mo PFS 77.1%; generator hypothesis signal

Population: Resectable stage IIIA NSCLC

In PD-L1≥1% stage II-IIIA DFS HR 0.66 (0.50-0.88); first adjuvant IO signal

Population: Resected stage IB-IIIA NSCLC post adjuvant chemo

pCR 24.0% vs 2.2%; EFS HR 0.63 (0.43-0.91); first phase III neoadj IO for NSCLC

Population: Resectable stage IB-IIIA NSCLC

Overall DFS HR 0.76 (0.63-0.91); PD-L1≥50% DFS HR 0.82 (NS); positive overall population

Population: Resected stage IB-IIIA NSCLC post adjuvant chemo

EFS HR 0.68 (0.53-0.88); pCR 17.2% vs 4.3%; durva perioperative benefit

Population: Resectable stage II-IIIB NSCLC

EFS HR 0.58 (0.46-0.72); mOS HR 0.72 (0.56-0.93); perioperative pembro significantly improves OS

Population: Resectable stage II-IIIB NSCLC

EFS HR 0.58 (0.42-0.81); pCR 25.3% vs 4.7%; nivo perioperative confirmed

Population: Resectable stage IIA-IIIB NSCLC

EFS HR 0.40 (0.28-0.57); MPR 48.5% vs 8.4%; Chinese PD-1 perioperative success

Population: Chinese resectable stage II-III NSCLC

MPR 56.2% vs 15.0%; EFS HR 0.56 (0.40-0.79); tislelizumab perioperative

Population: Chinese resectable stage II-IIIA NSCLC

No platinum doublet superior to another; mOS ~7.9 mo, 1-yr OS 33%; established 'no best regimen' plateau for unselected NSCLC

Population: Stage IIIB/IV advanced NSCLC, chemo-naive

DC vs VC: mOS 11.3 vs 10.1 mo, HR 1.183 (95% CI not explicitly in abstract); established docetaxel doublet as alternative 1L standard

Population: Stage IIIB/IV chemo-naive NSCLC

mOS 12.3 vs 10.3 mo, HR 0.79 (0.67-0.92); first biologic on doublet in 1L non-sq NSCLC

Population: Advanced non-squamous NSCLC, no brain mets, no hemoptysis

PFS HR 0.62 (0.49-0.79); established continuation maintenance of pemetrexed post cis+pem induction

Population: Non-sq NSCLC, non-progressing after 4 cycles cis+pem induction

Dato-DXd vs docetaxel in previously treated NSCLC: PFS HR 0.75; EGFR-mutated subgroup HR 0.38.