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Companies Prepare for ADC Trial Readouts at ASCO 2024

ReachMD Healthcare Image
05/20/2024
clinicaltrialsarena.com

As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event.

The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference.

In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer.

Pfizer will also be presenting data for an ADC, in this case Adcetris (brentuximab vedotin), which the company gained in its high-profile acquisition of Seagen. Pfizer will present evidence from the Phase III ECHELON-3 study (NCT04404283) of Adcetris in combination with lenalidomide and rituximab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The company previously released some data from the study in March 2024, which showed the therapy combination significantly improving the overall survival (OS) of enrolled patients. The company now plans to begin discussing a regulatory submission with the US Food and Drug Administration for Adcetris in this indication.

Astellas Pharma has announced plans to present 16 abstracts across its clinical portfolio, including data from its Phase III EV-302 trial (NCT04223856). The Phase III study is investigating the ADC Padcev (enfortumab vedotin) in combination with Merck & Co’s Keytruda (pembrolizumab) against chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma, including data in cisplatin-eligible and cisplatin-ineligible populations. The FDA approved the Padcev/Keytruda combination for the treatment of locally advanced or metastatic urothelial cancer in December 2023.

Astellas will also present OS data from the Phase III SPOTLIGHT study investigating Vyloy (zolbetuximab), which was in the news in January 2024 when the FDA issued a complete response letter rejecting Vyloy’s approval application due to “unresolved deficiencies” in the company’s manufacturing facility. Vyloy is a monoclonal antibody that has been investigated as a first-line treatment of patients with CLDN18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The therapy has since been approved in Japan for gastric cancer.

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Schedule25 Jun 2024