Patritumab

In the phase 2 SOLTI VALENTINE trial, patritumab deruxtecan (HER3-DXd) with or without letrozole showed similar pathologic complete response (pCR) and objective response rate (ORR) to multiagent chemotherapy in high-risk HR-positive, HER2-negative breast cancer, with fewer grade 3 or higher treatment-related adverse events (TRAEs). The antibody-drug conjugate (ADC) demonstrated biological evidence of antitumor activity and supported its potential in early breast cancer treatment.

AstraZeneca and Daiichi Sankyo's Dato-DXd received FDA Breakthrough Therapy designation for EGFRm NSCLC, based on phase II and III study data. They submitted a new BLA for accelerated approval in this indication and withdrew an earlier BLA for nonsquamous NSCLC. Dato-DXd is also under review for HR+ HER2- breast cancer, with regulatory applications ongoing globally.

FDA grants Merck's sacituzumab tirumotecan (sac-TMT) breakthrough therapy designation for advanced non-squamous NSCLC with EGFR mutations, post-chemotherapy progression. This marks the first BTD for sac-TMT, an ADC developed with Kelun-Biotech, with Merck holding global marketing rights except in Greater China.

Experts at the IASLC World Conference on Lung Cancer discussed HER2-directed treatments, highlighting recent approvals and clinical trial updates. They emphasized the importance of biomarker testing and safety profiles of HER2-targeted agents across cancer types. The panel debated the use of T-DXd in different lines of therapy for HER2-mutated non-small cell lung cancer (NSCLC) and the potential of TKIs like zongertinib and BAY 2927088. They also explored the implications of HER2 expression in tumor-agnostic trials and the role of AI in predicting patient responses.

Daiichi Sankyo and AstraZeneca awarded 2024 Prix Galien USA for Enhertu, a HER2-directed ADC. Enhertu, developed jointly, is transforming HER2+ solid tumour treatment. The Galien Foundation recognizes impactful FDA-approved treatments, honoring medical innovation.

At the 2024 ESMO Congress, significant advancements in breast cancer therapeutics were highlighted, including final overall survival data from KEYNOTE-522, 4-year update from NATALEE, intracranial activity of T-DXd in DESTINY-Breast12, phase 2 results of HER3-DXd in ICARUS-BREAST01, and beneficial effects of exercise on quality of life and survival.

Antibody-drug conjugates (ADCs) are emerging in oncology, with dozens approved by the FDA. ADCs offer a 'bystander effect' but can increase off-target toxicity. Aditya Bardia highlighted ADCs like sacituzumab govitecan, trastuzumab deruxtecan, and datopotamab deruxtecan, which show superiority over chemotherapy in metastatic settings. Domenica Lorusso noted over 260 ADCs in cancer trials, calling them a 'rising star' in ovarian cancer. Toon Van Gorp emphasized TROP2 as a key target in cervical cancer. Challenges include understanding ADC resistance mechanisms and managing toxicities, necessitating multidisciplinary approaches.

FDA approves Eli Lilly’s Ebglyss for eczema, Novartis’ Kisqali for early breast cancer, Merck’s Keytruda for malignant pleural mesothelioma, J&J’s Rybrevant for advanced lung cancer, and AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis.

Merck & Co and Daiichi Sankyo's late-stage trial of patritumab deruxtecan in EGFR-mutated NSCLC met primary endpoint of PFS, showing significant improvement over standard chemotherapy. The trial continues to assess overall survival, with plans to discuss findings with regulatory authorities.

Cancer patients seek early financial advice; FDA expands Keytruda approval; overweight/obese patients at higher risk for second cancers; novel three-drug regimen shows 80% response rate; patritumab deruxtecan meets progression-free survival endpoint; Oncternal terminates clinical trials; Ultimovacs halts enrollment; bipartisan Senate bill targets misleading drug ads; Trojan condoms face lawsuit over 'forever chemicals'; Ossium Health achieves first successful stem-cell transplant; higher incarceration rates linked to cancer mortality; FDA issues guidance on multiregional cancer trials.