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

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Thomas J. Lynch Jr. and Howard A. “Skip” Burris III lead two institutions that couldn’t be more different—an NCI-designated Comprehensive Cancer Center on one side of the country and a for-profit research enterprise on the other—but they stay up at nights worrying about the same thing.

New compound targets circadian clock machinery in cells to fight glioblastoma

A series of preclinical studies show that a new compound, SHP1705, targets circadian clock proteins hijacked by glioblastoma stem cells, impairing the cancer cells’ ability to survive and grow.

May 16, 2025

Vol.51 No.19

Clinical Roundup

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Positive high-level results from the POTOMAC phase III trial showed one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer compared to BCG induction and maintenance therapy alone.

May 09, 2025

Vol.51 No.18

Clinical

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

When Kelly Spill was eight months pregnant, she experienced some constipation and noticed blood in her stool. Her OBGYN wasn’t worried.

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

Pfizer Inc. on April 26 announced results from the pivotal phase III CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with standard-of-care Bacillus Calmette-Guérin as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer.

May 02, 2025

Vol.51 No.17

Clinical Roundup

TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in certain bladder cancers

Johnson & Johnson on April 26 announced new data from cohort 2 of the pivotal phase IIB SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer.

May 02, 2025

Vol.51 No.17

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

YOU MAY BE INTERESTED IN

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

New compound targets circadian clock machinery in cells to fight glioblastoma

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in certain bladder cancers

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

YOU MAY BE INTERESTED IN

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient livesIn a time of uncertainty, “react to the knowns, not the fear”

New compound targets circadian clock machinery in cells to fight glioblastoma

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertileSix years later, she is well—and pregnant with her third child

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in certain bladder cancers

Never miss an issue!

Login

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child