DAIICHI SANKYO, INC.

Post-hoc analysis in DESTINY-Breast12 showed CNS ORR of 82.6% in patients without prior CNS therapy and 50.0% in those with prior therapy. Safety profiles of Enhertu were consistent with previous trials, with no new concerns. ILD/pneumonitis rates were 12.9% and 16.0% in patients without and with brain metastases, respectively, with most events being low grade.

Datopotamab failed to significantly increase overall survival in a Phase III study for non-small cell lung cancer, but a new biomarker and encouraging data in a subset of patients highlight the potential of precision medicine.

Immunotherapy less risky for non-small cell lung cancer patients with BMI under 28, while chemotherapy is optimal for those with BMI 28 or higher, according to Osaka Metropolitan University study.

ALX Oncology Holdings Inc. develops Evorpacept [ALX148], a first-in-class CD47 inhibitor with an inactive Fc domain reducing side effects. ASPEN-06 Phase 2 trials combining Evorpacept with trastuzumab, ramucirumab, and paclitaxel (TRP) showed favorable results in HER2-positive gastric and gastroesophageal junction (GEJ) cancer. Evorpacept has FDA Fast Track designations for several indications, making the shares potentially bullish.

IDeate-Lung01 study interim analysis shows ifinatamab deruxtecan (I-DXd) at 12 mg/kg has 54.8% confirmed objective response rate (ORR) in extensive-stage small cell lung cancer (SCLC), significantly higher than 8 mg/kg dose (26.1% ORR). Higher dose also shows better disease control rate and intracranial activity.

AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan showed a 2.3-month survival advantage in nonsquamous non-small cell lung cancer patients, but lacked statistical significance. FDA approval by Dec. 20 is uncertain, with a potential advisory committee meeting. The drug, an antibody-drug conjugate, aims to replace chemotherapy but faces complexities in identifying responders.

Datopotamab deruxtecan (Dato-DXd) showed no statistically significant overall survival improvement in phase III TROPION-Lung01 trial for advanced or metastatic NSCLC, except in non-squamous NSCLC subgroup. AstraZeneca and Daiichi Sankyo focus on this subgroup, highlighting potential role of Dato-DXd in non-small cell lung cancer.

TROPION-Lung01 trial results show datopotamab deruxtecan improves overall survival (OS) over docetaxel in nonsquamous NSCLC patients, with a mean OS improvement of 2.3 months. Developed by Daiichi Sankyo and AstraZeneca, the TROP2-directed ADC is under review for marketing authorisation in NSCLC and HER2-negative breast cancer. The NSCLC market is projected to grow to $45.4bn by 2031, with datopotamab deruxtecan estimated to generate $6bn in annual global sales by 2030.

AstraZeneca's London-listed shares fell 5.6% after lung cancer trial results showed its experimental drug did not significantly improve overall survival. The TROPION-Lung01 trial's overall survival rates did not reach statistical significance, according to a presentation at the World Conference on Lung Cancer.

AstraZeneca and Daiichi Sankyo's Phase III TROPION-Lung01 study showed datopotamab deruxtecan (Dato-DXd) failed to significantly improve overall survival in non-small cell lung cancer patients, with a 6% drop in death risk and 16% OS benefit in non-squamous NSCLC, both missing statistical significance. Despite this, AstraZeneca remains confident in Dato-DXd's potential role in lung cancer treatment.