OBR Daily Commentary

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Bristol-Myers Squibb Announces Results from CheckMate -459 Study Evaluating Opdivo (nivolumab) as a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

(BMS) June 24, 2019 - Bristol-Myers Squibb Company today announced topline results from CheckMate -459, a randomized Phase 3 study evaluating Opdivo (nivolumab) versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC). The trial did not achieve statistical significance for its primary endpoint of overall survival (OS) per the pre-specified analysis (HR=0.85 [95% CI: 0.72-1.02]; p=0.0752). No new safety signals were observed with Opdivo. The full study results will be presented at an upcoming medical meeting.

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Howard S. Hochster, MD (Posted: June 24, 2019)

quotesIt is clear that anti-PD(L)1 drugs have benefit for some patients with HCC. But the perspective that these data are from relatively small trials of heavily pre-selected patients, who have managed to survive beyond first-line sorafenib, has been lost in the enthusiasm of bringing immuno-therapy to all patients. The stakes are high and this first randomized trial of nivolumab vs sorafenib again demonstrates the complexity of patient selection (or lack thereof). In more than 1000 first-line patients randomized, nivolumab was not statistically superior to sorafenib, though it came quite close. Again better selection of appropriate patients would have made this a positive trial, and we may yet see this in the future. In the meantime, multiple other trials of anti-PD1 and TKIs vs sorafenib (ImBRAVE, COSMIC, etc) are well underway. These results can only temper our expectations.quotes

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Lynparza Approved In The EU For 1st-line Maintenance Treatment Of BRCA-Mutated Advanced Ovarian Cancer

(AstraZeneca) June 18, 2019 - AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. The licensed indication is as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.

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Howard S. Hochster, MD (Posted: June 18, 2019)

quotes For patients with germline BRCA mutations, the risk of many cancers and including breast, ovarian and pancreatic cancer are quite elevated. These tumors are sensitive to platinum based chemotherapy, and the option to use PARP inhibitors, such as olaparib, as maintenance maintenance provides a relatively non-toxic treatment option for these patients. This was also shown in the POLO study for BRCA-related pancreatic cancer with a more than doubling in PFS on maintenance. Some patients responded further by scan and these had median benefit of more than 2 years. The challenge is to extend this finding to other platinum sensitive tumors with DNA Damage Repair defects and to extend the use of these agents to more patients. quotes

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Array BioPharma Announces Braftovi + Mektovi + Cetuximab Meet Primary Endpoints of ORR and OS in Phase 3 BEACON CRC Trial Interim Analysis for the Treatment of BRAF(V600E)-mutant Metastatic Colorectal Cancer

(Array) May 21, 2019 - Braftovi combinations showed statistically significant improvement in ORR and OS versus control. Braftovi + Mektovi + cetuximab reduced the risk of death by 48% versus control. Potential to be the first chemotherapy-free, targeted regimen for metastatic CRC patients.

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Howard S. Hochster, MD (Posted: May 22, 2019)

quotesIn a long expected result, the 2nd-3rd line BEACON trial of encorafenib and binimetinib (with or without cetuximab) compared with the standard Irinotecan and cetuximab, in a 3-arm randomized trial (N=663) showed the benefit of these improved BRAF and MEK inhibitors for BRAF-mutated mCRC. These newer generation signal transduction inhibitors were expected to show improved outcomes compared with earlier inhibitors, based on prior results. The triplet showed improved RR (26 vs . 19%) compared with the standard arm and OS (9.0 vs 5.4 months), both reaching statistical significance. The triplet was better than the doublet but this did not reach statistical significance. Both of these kinase inhibitors are already approved for melanoma, and fall within the NCCN guidelines. This regimen should be considered a standard for the 8% of mCRC with BRAF mutation, following FOLFOX first line therapy. Another option is irinotecan, cetuximab and vemurafenib as shown in the S1406 trial, also chaired by Scott Kopetz. While a small subset of mCRC, this is the first "all biologic" combination therapy in CRC and a great step forward for patient therapy. quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

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

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

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

Lung Cancer
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H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

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

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

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Jennifer Levin Carter, MD, MPH

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

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...