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October 2014PDF

 Lung Cancer

Gilotrif Increases PFS Compared to Erlotinib In LUX-Lung 8 Phase III Head-to-Head Trial


Phase III data from the LUX-Lung 8 head-to-head trial, evaluating Gilotrif versus erlotinib in patients with advanced squamous cell carcinoma of the lung, demonstrated superior improvement in progression-free survival with Gilotrif.

The trial demonstrated that Gilotrif (afatinib) significantly reduced the risk of disease progression by 18 percent when compared to erlotinib and delayed tumor growth (PFS by independent review: 2.4 vs. 1.9 months; HR=0.82; p=0.043). Overall survival data are not yet mature.

Treatment with Gilotrif showed improvement in the secondary endpoint of disease control rate compared to erlotinib, 45.7 vs. 36.8 percent, respectively (p=0.020). Objective response rate was 4.8 percent in the Gilotrif arm compared to 3.0 percent in the erlotinib arm (p=0.233). 

 Melanoma

Cobimetinib-Zelboraf Therapy Increases OS In BRAF V600 Mutation-Positive Disease

A phase III trial showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who received the MEK inhibitor cobimetinib plus Zelboraf (vemurafenib) lived significantly longer without their disease worsening or death compared to Zelboraf alone.

The combined therapy reduced the risk of disease worsening or death by half (HR=0.51, 95% CI 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. 

 Prostate Cancer

Zytiga and Prednisone Extends Overall Survival in mCRPC Trial

A final analysis of a phase III trial showed that Zytiga (abiraterone acetate) plus prednisone significantly prolonged overall survival compared to an active control of placebo plus prednisone, in men with chemotherapy-naïve metastatic castration-resistant prostate cancer.

The study demonstrated a 19 percent reduction in risk of death in this study population, with a median OS of 34.7 compared to 30.3 months respectively (HR= 0.81 [95% CI, 0.70-0.93]; p = 0.0033), after a median follow-up of more than four years (49.2 months).

 Thyroid Cancer
Study: Angiopoietin-2 Levels May Predict Lenvatinib Response
 Head and Neck Cancer
Afatinib Delays Tumor Growth In LUX-Head and Neck 1 Study
 Cachexia
Anamorelin Increases Body Mass In Two Global Phase III Trials
 NCI CTEP-Approved Trials for the Month of October
 Drugs and Targets

  • Velcade Injection approved in Mantle Cell Lymphoma

  • Akynzeo approved for nausea and vomiting following chemotherapy

  • European Commission approves Imbruvica in MCL and CLL

  • CMS publishes two draft local coverage determinations for prostate cancer tests

  • FDA grants aldoxorubicin orphan drug designations in three indications

  • Blinatumomab granted priority review in ALL

20141030 - Oct. 30, 2014
ISSUE 40 – OCT. 24, 2014PDF



40 Years Later
Doctor and Patient Reflect on the Cure

On Oct. 21, 1974, John Cleland lay in a hospital bed at Indiana University Hospital.

At 23, he had just graduated from Purdue University and just married.

He was also three weeks into a fourth-line chemotherapy regimen for advanced metastatic testicular cancer. The disease had spread to his lungs.

Lawrence Einhorn, Cleland’s doctor, told him that this was the end of the road.

Conversation with The Cancer Letter
Einhorn: “I Still Harbor Hope For Similar Success Stories”

The Cancer Letter asked Lawrence Einhorn, distinguished professor of medicine and the Livestrong Foundation Professor of Oncology at the Indiana University Melvin and Bren Simon Cancer Center, to reflect on one of the most spectacular successes in the history of cancer research—his development of the curative regimen for testicular cancer.

Caris Life Sciences Lays Off Estimated 20 Percent of Staff

Caris Life Sciences Inc. last week reduced its workforce by 50 people—about 20 percent, sources said.

While a 50-person reduction in force is small by pharma industry standards, the development could be significant because Caris is a key player in the emerging market for molecular therapies.

HRSA: Discounts Owed on Some Orphan Drug Uses

The Health Resources and Services Administration last week warned pharmaceutical companies that they must continue to offer 340B Drug Pricing Program discounts on some uses of orphan drugs.

Cancer Support Community Reports on Patient Experiences

Cancer Support Community released the findings report from the first year-and-a-half of the Cancer Experience Registry.

Institute of Medicine Elects 80 New Members

The Institute of Medicine named 70 new members and 10 foreign associates during its 44th annual meeting.

New members are elected by current active members through a selective process that recognizes individuals who have made major contributions to the advancement of the medical sciences, health care, and public health.

photoIn Brief

  • Benjamin Neel named director of NYU Cancer Center

  • Brad Pollock named chair of public health department at UC Davis

  • Richard Zellars named chair of radiation oncology at IU School of Medicine

  • David Mauro named chief medical officer and VP of Advaxis Inc.

  • James Tulsky receives award from American Cancer Society

  • Mary Kozik named senior director of development at Winship Cancer Institute

  • Northwestern Mutual and Alex’s Lemonade Stand fund eight young investigators

  • Association of Community Cancer Centers receives gift from Bristol-Myers Squibb

  • Stand Up To Cancer epigenetics dream team receives $7.5 million from Van Andel Research Institute

photoDrugs and Targets

  • EU approves Imbruvica in MCL, CLL

  • CMS publishes two draft coverage determinations for molecular prostate cancer tests

  • Priority Health to cover FoundationOne genomic profiles

  • Celgene and Sutro Biopharma to collaborate on antibody-drug conjugates

20141024 - Oct. 24, 2014
ISSUE 39 – OCT. 17, 2014PDF



Indiana to Close Proton Beam Facility
Amid Nationwide Building Boom

At its opening a decade ago, the Indiana University Health Proton Therapy Center was one of four such facilities in the U.S.

Alas, money woes struck immediately. The center has run at a deficit for most of its existence—recently losing over $3.5 million in operating costs in fiscal 2013. And now the center is a landmark once again: On Jan. 1, 2015, it will become the first proton beam center in the U.S. to be closed.

Conversation with The Cancer Letter
IU’s Loehrer Discusses “Business Decision” To Close Bloomington Proton Beam Center

The Cancer Letter asked Patrick Loehrer, director of the Indiana University Melvin & Bren Simon Cancer Center, to discuss his institution’s decision to close its 10-year-old proton beam center.

No other institution in the U.S. has closed such a facility. 

Genentech Reps Not Welcome

Hospitals Urge Drug Maker to Reverse Policy

On Supplying Avastin, Rituxan, & Herceptin

Cancer centers and other hospitals, reeling from the loss of discounts and rebates on three widely used cancer drugs, are seeking to persuade drug maker Genentech to reverse its decision to channel these medications through six specialty distributors.

ASCO Endorses Guideline for Molecular Testing

The American Society of Clinical Oncology endorsed a joint clinical practice guideline on molecular testing published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. 

IARC Publishes Fourth Edition of European Code Against Cancer

The fourth edition of the European Code Against Cancer was published by the International Agency for Research on Cancer, with the participation of the European Commission. 

Funding Opportunity

Stand Up To Cancer Canada to Fund Two Dream Teams

Stand Up To Cancer Canada will support two, four-year cancer research dream teams with nearly $20 million USD raised by SU2C Canada collaborators and from the charity’s September telecast. The dream teams will focus their research on translational research in breast cancer and cancer stem cells.

photoIn Brief

  • Francis Giles named deputy director of Lurie Cancer Center

  • Zhu Chen honored by American Association for Cancer Research

  • Lili Yang receives $2.3 million award from NIH

  • Indiana University Simon Cancer Center re-designated as NCI cancer center

  • Cancer Treatment Centers of America launch fertility preservation program

  • Lurie Cancer Center to collaborate with Perthera Inc.

  • ASCO publishes survivorship care plan template

photoDrugs and Targets

  • FDA approves Velcade in mantle cell lymphoma

  • Priority Review granted to lenvatinib in thyroid cancer

  • Blinatumomab granted Priority Review in acute lymphoblastic leukemia

20141017 - Oct. 17, 2014