OBR Daily Commentary

forumImage

Five Prime Therapeutics Provides Update on Phase 2 Trial of Cabiralizumab Combined with Opdivo® in Pancreatic Cancer

(Five Prime) Feb 18, 2020 - Five Prime Therapeutics, Inc. today announced that Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase 2 trial.

Read Article arrow

Howard S. Hochster, MD (Posted: February 18, 2020)

quotesAnother "swing and a miss" in pancreatic cancer. Despite numerous trial of chemotherapy plus targeted drugs, and now plus IO drugs, we have not seen a benefit. Cabiralizumab had more than the typical preclinical data (and hype) as it is an antibody to CSF1 on infiltrating lymphocytes and especially TAMs (Tumor Associated Macrophages) which are believed to be immunosuppressive. The antibody would block this kind of immunosuppression and allow anti-PD1 to work (like in melanoma!). Unfortunately this simple solution was not to be. So far finding effective IO approaches to pancreatic cancer still remains the "holy grail". quotes

Add Comment 1 Comment
forumImage

Roche Submits Supplemental Biologics License Application To The FDA For Tecentriq In Combination With Avastin For The Most Common Form Of Liver Cancer

(Roche) Jan 27, 2020 - Roche today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.

Read Article arrow

Howard S. Hochster, MD (Posted: February 04, 2020)

quotesThe results o f IMbrave 150 for Child-Pugh A HCC should set a new standard for treatment of advanced HCC and the sBLA should be rapidly improved. This global study randomized (2:1) Atezolizumab and Bevacizumab (both iv q3w) vs sorafenib 400 mg bid. The OS showed 42% improvement with HR of 0.58 (p=0.0006). PFS and RR were both statistically improved with the IO arm. This was the single positive study presented at GI ASCO with prior results at ESMO-Asia and PRO data showing similar improvement in HR for deterioration in QOL, Physical Function, Role Function (with HR 0.53-0.63), favoring the experimental arm. This represents a substantial treatment advance over sorafenib for HCC.quotes

Add Comment 1 Comment
forumImage

Exelixis Announces Results for Combination of Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Hepatocellular Carcinoma

(Exelixis) Jan 24, 2020 - Exelixis, Inc. today announced phase 1/2 clinical trial results from the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced hepatocellular carcinoma (HCC).

Read Article arrow

Howard S. Hochster, MD (Posted: January 24, 2020)

quotesInteresting but not overwhelming response rates, especially when compared with pretreated patients who then received atezolizumab and bevacizumab. The new question in GI cancers - do TKIs turn anti-PD1 drugs into active agents for the otherwise not very responsive tumors? Time (and hopefully phase 3 trials) will tell. quotes

Add Comment 1 Comment

Meet the Editorial Board

Prostate Cancer
member photo
Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
member photo
H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Community Oncology
member photo
Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
member photo
Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
member photo
Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
member photo
Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
member photo
Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
member photo
William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...

Payer
member photo
Winston Wong, PharmD

President, W-Squared Group...