Shots:
The global P-III (REZILIENT3) trial data assessed zipalertinib + CT vs CT in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations
After a 6-patient safety lead-in, 279 pts were randomized to zipalertinib (100mg, BID) + CT (n=140) or CT alone (n=139); as previously reported, the trial met…
Shots:
Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs Pt-pemetrexed doublet CT + Keytruda as the 1L treatment in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation
Enhertu improved PFS by 37% (mPFS: 14.3 vs 8.3mos.) & showed ORR of 70%…
Shots:
The US FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic non-squamous NSCLC harboring HER2/ERBB2 TKD-activating mutations
Approval was supported by ORR & DoR results from the Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo in treatment-naïve…
Shots:
Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression
Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…
Shots:
The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression
The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…
Shots:
Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC)
Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…
Shots:
The P-III (SAFFRON) trial assessed Orpathys (300mg; BID) + Tagrisso (80mg; QD) vs doublet Pt-based CT in 338 pts with EGFRm, LA/M NSCLC with MET overexpression or amplification whose disease progressed following 1 or 2L treatment with Tagrisso
The trial showed a statistically significant & clinically meaningful improvement in both PFS & OS, with a favorable…
Shots:
Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs SoC (Pt-pemetrexed doublet CT + Keytruda) in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation
Trial showed that Enhertu improved PFS as 1L treatment, with trial continuing to evaluate 2EPs incl. OS;…
Shots:
Chinese NMPA has approved ivonescimab + CT for the 1L treatment of pts with advanced squamous NSCLC (sqNSCLC), based on the global P-III (HARMONi-6) trial
The trial, sponsored by Akeso, assessed ivonescimab + CT vs Tevimbra + CT to treat Chinese pts with 1L sqNSCLC irrespective of PD-L1 expression, showing improved OS & PFS;…
Shots:
The companies have reported the global P-III (REZILIENT3) trial assessing zipalertinib + Pt-based CT vs CT alone in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations
Trial met its 1EP of PFS, showing improvement with the zipalertinib-containing regimen at interim analysis, with the IDMC recommending unblinding the…

