How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

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

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.

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

The ASCERTAIN-V phase I/II clinical trial, which evaluated the first all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive induction chemotherapy, demonstrated favorable response rates and survival with expected myelosuppressive effects.

June 18, 2026

Vol.52 No.24

How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

YOU MAY BE INTERESTED IN

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

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

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

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