AstraZeneca and Daiichi Sankyo’s Enhertu recommended for EU approval

AstraZeneca and Daiichi Sankyo’s Enhertu recommended for EU approval

AstraZeneca and Daiichi Sankyo’s Enhertu has been recommended for approval in the European Union (EU) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). Specifically designed for tumors with an activating HER2 (ERBB2) mutation, the drug aims to fill a significant gap in systemic therapy options following platinum-based chemotherapy. Enhertu’s EU […]

Gilead’s EVOKE-02 study of Trodelvy, KEYTRUDA combo shows promise in NSCLC

Gilead’s EVOKE-02 study of Trodelvy, KEYTRUDA combo shows promise in NSCLC

Gilead Sciences, Inc. announced early data showcasing promising clinical activity of Trodelvy in combination with Merck’s KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). The data was presented at the IASLC 2023 World Conference on Lung Cancer and focuses on patients without actionable genomic alterations. EVOKE-02 Preliminary Analysis: Notable Response Rates Across […]

Patritumab Deruxtecan Phase 2 trial unveils encouraging outcomes in metastatic NSCLC

Patritumab Deruxtecan Phase 2 trial unveils encouraging outcomes in metastatic NSCLC

The HERTHENA-Lung01 Phase 2 trial, presented at the 2023 World Conference on Lung Cancer by Daiichi Sankyo, demonstrated that Patritumab Deruxtecan has potential for treating EGFR-mutated metastatic non-small cell lung cancer (NSCLC). The drug revealed a confirmed objective response rate (ORR) of 29.8% in 225 patients, with a median progression-free survival of 5.5 months and […]

Genentech’s Alecensa shows promise in Phase III ALINA study for early-stage ALK-positive NSCLC

Genentech’s Alecensa shows promise in Phase III ALINA study for early-stage ALK-positive NSCLC

Genentech, a Roche Group member, has announced positive results from its Phase III ALINA study evaluating Alecensa (alectinib), setting a new standard for treating early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Meeting its primary endpoint of disease-free survival (DFS), Alecensa showed a statistically significant and clinically meaningful improvement compared to platinum-based chemotherapy. […]

Exscientia begins enrollment for Phase 1/2 cancer trial of CDK7 inhibitor

Exscientia begins enrollment for Phase 1/2 cancer trial of CDK7 inhibitor

AI-driven precision medicine company Exscientia has initiated enrollment for its Phase 1/2 “ELUCIDATE” study, marking the first trial of its precision-designed CDK7 inhibitor, GTAEXS617 (‘617), in the treatment of advanced solid tumours. The trial aims to investigate the safety, efficacy, and pharmacokinetics of GTAEXS617 through multiple ascending doses for patients with advanced solid tumours, including […]

BMS to acquire precision oncology company Turning Point Therapeutics for $4.1bn

BMS to acquire precision oncology company Turning Point Therapeutics for $4.1bn

Bristol Myers Squibb (BMS) has agreed to acquire Turning Point Therapeutics, a clinical-stage precision oncology company based in California, for $4.1 billion. Listed on the Nasdaq, Turning Point Therapeutics is developing drug candidates that are said to target the highly common mutations related to oncogenesis. Its flagship asset is repotrectinib, which is a tyrosine kinase […]

FDA rejects Lilly’s sintilimab as first line treatment of NSCLC

FDA rejects Lilly’s sintilimab as first line treatment of NSCLC

The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and Company (Lilly)’s sintilimab injection in nonsquamous non-small cell lung cancer (NSCLC). Lilly has been issued a complete response letter (CRL) for the BLA for the PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy. The US pharma […]

AstraZeneca reports positive results for phase 2 COAST trial of oleclumab and monalizumab

AstraZeneca reports positive results for phase 2 COAST trial of oleclumab and monalizumab

AstraZeneca has reported positive results from the COAST phase 2 trial of its oleclumab or monalizumab in combination with Imfinzi (durvalumab) in patients with non-small cell lung cancer (NSCLC). The pharma giant said that the mid-stage clinical trial showed the experimental combinations to have improved progression-free survival (PFS) as well as objective response rate (ORR). […]