Perioperative Imfinzi + neoadjuvant EV improved EFS and OS in muscle-invasive bladder cancer, phase III VOLGA trial shows

To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements

HHS earlier this week rolled out a cluster of initiatives related to simplifying clinical trials, presenting these measures as a government-wide effort to maintain America’s leadership in early-stage drug development.

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

Sigvotatug vedotin, an integrin beta-6 directed antibody-drug conjugate, did not show a statistically significant improvement in the primary endpoint of overall survival, compared to docetaxel, according to the results of the phase III SigVie-002 study (previously known as Be6A Lung-01).

June 26, 2026

Vol.52 No.25

Drugs & Targets

EC approves Padcev + Keytruda as perioperative treatment option for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer

The European Commission granted Marketing Authorization for Padcev (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy in the European Union.

June 26, 2026

Vol.52 No.25

Clinical Trials & Tribulations

What NHS-Galleri taught us—and what it didn’t

On May 30, GRAIL reported the full results of the NHS-Galleri trial in an oral presentation at the ASCO Annual Meeting.

June 18, 2026

Vol.52 No.24

By Scott D. Ramsey and Ruth Etzioni

Clinical Trials & Tribulations

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

The NHS-Galleri trial presented at ASCO was the largest, prospective, randomized trial of a multicancer early detection test (MCED) to date. The study enrolled approximately 143,000 asymptomatic adults (ages 50-77) and was the first of its kind to assess clinical utility of an MCED test for cancer screening.

June 18, 2026

Vol.52 No.24

By Bryan Bassig, Catherine R. Marinac, David M. Routman, Elizabeth K. O'Donnell, Jennifer Keating Litton, Karthik V. Giridhar, Kennedy Ng Yao Yi, Kurt Giles, Nima Nabavizadeh, Ora K. Gordon, Rebecca Kaltman and Shawn Kothari

Cancer Policy

OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds

An analysis by Stand up for Science found that the White House Office of Management and Budget’s recently proposed rule, “Regulation for Federal Financial Assistance,” if finalized, could result in termination of nearly 50% of active clinical research studies.

June 18, 2026

Vol.52 No.24

By Jacquelyn Cobb

Perioperative Imfinzi + neoadjuvant EV improved EFS and OS in muscle-invasive bladder cancer, phase III VOLGA trial shows

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To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

EC approves Padcev + Keytruda as perioperative treatment option for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer

What NHS-Galleri taught us—and what it didn’t

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds

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