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FDA Grants Label Expansion to AstraZeneca's Datroway in Lung Cancer
ZACKS· 2025-06-24 14:05
Core Insights - AstraZeneca (AZN) received FDA approval for its cancer drug Datroway for non-small cell lung cancer (NSCLC), expanding its label for a second indication [1][3] - The approval was based on clinical studies showing a 45% objective response rate (ORR) [2][7] - Datroway is the first TROP2-directed therapy approved in the U.S. for lung cancer [3] Company Performance - Year-to-date, AstraZeneca's shares have increased by 8%, while the industry has seen a 3% decline [4] Product Development - Datroway is the second antibody-drug conjugate (ADC) developed under the AstraZeneca-Daiichi partnership, following Enhertu [6] - The companies are jointly responsible for the development and marketing of Datroway, except in Japan where Daiichi has exclusive rights [6] - AstraZeneca and Daiichi are conducting extensive clinical trials for Datroway across multiple cancer indications, including eight late-stage studies in lung cancer and five in breast cancer [8] Market Potential - Datroway is projected to achieve peak annual sales of at least $5 billion, contributing to AstraZeneca's goal of reaching $80 billion in annual revenues by 2030 [9] - ADCs like Datroway are considered disruptive innovations in the pharmaceutical industry, enhancing cancer treatment through targeted delivery of cytotoxic drugs [9]
Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting
Prnewswire· 2025-06-02 12:00
Core Insights - Eli Lilly and Company announced promising Phase 1 data for its folate receptor alpha (FRα) antibody-drug conjugate (ADC) LY4170156, showing a preliminary overall objective response rate (ORR) of 55% in women with heavily pre-treated platinum-resistant ovarian cancer [1][2][3] Group 1: Clinical Data and Efficacy - The study enrolled 95 participants with high-grade serous ovarian cancer, with a median of five prior systemic regimens [2][3] - Among the 95 patients, 51% had tumors with FRα expression less than 75%, while 34% had expression of 75% or higher [2] - The ORR was 45% in 58 efficacy-evaluable patients, with a disease control rate of 74% [3] Group 2: Safety Profile - The most common treatment-emergent adverse events included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%) [3] - No maximum tolerated dose has been established, and treatment-emergent neuropathy and ocular toxicity have not been observed to date [3] Group 3: Future Directions - Based on the results, the company aims to advance LY4170156 into registrational Phase 3 clinical trials [4] - The ADC is designed to target FRα across expression levels with an improved therapeutic index, potentially benefiting a larger number of ovarian cancer patients [5]
Genmab to Highlight New Data Evaluating Late-Stage Oncology Portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-05-22 21:05
Core Insights - Genmab A/S will present new research from its late-stage portfolio at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago, Illinois [1] - The presentations will include results from a Phase 1/2 trial of rinatabart sesutecan (Rina-S) for recurrent/advanced endometrial cancer and long-term follow-up data from the EPCORE NHL-1 study of epcoritamab in relapsed/refractory diffuse large B-cell lymphoma [2][8] Company Commitment - Genmab emphasizes its commitment to advancing antibody science for patients needing alternative treatment options, particularly for endometrial cancers with rising mortality rates [3] - The company is encouraged by Rina-S as a potential treatment option for endometrial cancer and continues to evaluate epcoritamab as a core therapy across B-cell malignancies in collaboration with AbbVie [3][15] Event Details - Genmab will host a virtual review of the Rina-S data presented at ASCO on June 2 at 4:00 PM CDT, with details available on their investor relations website [4] Abstracts and Presentations - Abstracts accepted for presentation at ASCO include key studies on Rina-S and epcoritamab, with specific presentation times outlined [5][7]