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Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and AstraZeneca plc (NASDAQ:AZN) released initial results from the TROPION-Lung04 phase 1b trial.
The study showed that datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, with or without carboplatin demonstrated encouraging responses and no new safety signals in patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
In previously untreated patients, datopotamab deruxtecan plus durvalumab (doublet; n=14) demonstrated an objective response rate (ORR) of 50.0%, including seven partial responses (PR) and a disease control rate (DCR) of 92.9%.
Response rates were higher in patients receiving datopotamab deruxtecan plus durvalumab and carboplatin (triplet; n=13), demonstrating an ORR of 76.9%, including 10 PRs and a DCR of 92.3%. Responses were observed across PD-L1 expression levels.
In both previously treated and untreated patients, the safety profiles of datopotamab deruxtecan and durvalumab with and without carboplatin were consistent with other clinical trials and with the known safety profile of each agent.
No grade 5 interstitial lung disease events were observed.
AstraZeneca also released data from the FLAURA2 Phase 3 trial showing Tagrisso (osimertinib) in combination with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone in patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
By investigator assessment, The combination extended median progression-free survival by 8.8 months versus Tagrisso alone.
PFS results from blinded independent central review (BICR) were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months.
The overall survival (OS) data were immature; however, a favorable trend was observed for Tagrisso plus chemotherapy.
The company additionally announced primary analysis data of the DESTINY-Lung02 Phase 2 trial of Enhertu (fam-trastuzumab deruxtecan-nxki) in previously treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).
The data showed Enhertu continued to demonstrate strong and durable tumor responses.
A confirmed objective response rate (ORR) of 49.0% and 56.0% was seen in the 5.4mg/kg arm and 6.4mg/kg arm, respectively.
Enhertu also demonstrated a median progression-free survival of 9.9 months and 15.4 months in the 5.4mg/kg and 6.4mg/kg arms, respectively.
A median overall survival of 19.5 months was achieved in the 5.4mg/kg arm and not reached in the 6.4mg/kg arm.
Price Action: AZN shares are down 3.21% at $66.03 on the last check Monday.
