Special Issues


August 2016, Vol 7, No7, Special Issue: Payers’ Perspectives in Oncology

“Smart Bomb” First-in-Class Drug Rova-T Promising Novel Therapy for Small-Cell Lung Cancer

Phoebe Starr

Emerging Therapies

The first-in-class antibody-drug conjugate rovalpituzumab tesirine (Rova-T) may be a new treatment option for patients with small-cell lung cancer (SCLC), which has a very poor prognosis and few treatment options. Rova-T is particularly promising in SCLC tumors that overexpress the delta-like (DLL) 3 protein, according to first-in-human study results presented at ASCO 2016.

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The Oncology Drug Pipeline Shows No Evidence of Slowing Down

Wayne Kuznar

Emerging Therapies

Oral and poster presentations of several promising agents in early- and late-phase clinical trials dotted the program at ASCO 2016. The presentations included studies with positive findings associated with many investigational therapies, including first-in-class therapies such as chimeric antigen receptor (CAR) T-cells for the treatment of patients with B-cell malignancies or acute myeloid leukemia (AML); a vaccine (galinpepimut-S) for the treatment of patients with AML; and a chimeric monoclonal antibody against claudin 18.2 for the treatment of patients with advanced gastric cancers.

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Healthcare Resource Utilization High in Patients with Relapsed or Refractory Multiple Myeloma

Chase Doyle

Value in Oncology

A study evaluating the economic burden associated with multiple myeloma and its treatment has found that routine management and disease progression continues to drive healthcare resource utilization, regardless of the number of previous lines of therapy. Other key drivers of healthcare utilization in multiple myeloma are hospitalizations, transplantations, and concomitant medication use. The study was presented at ASCO 2016.

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In the Literature – August 2016

In the Literature

  • Ixazomib Extends Progression-Free Survival in Multiple Myeloma
  • Pembrolizumab Shows Potential Antitumor Activity in Advanced Gastric Cancer
  • ASCO Endorses Canadian Clinical Practice Guideline on Active Surveillance for Localized Prostate Cancer
  • Delayed Relapses After Anti–PD-1 Therapy Linked to Mutation in Patients with Melanoma
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Adding the BCL-2 Inhibitor Venetoclax to Treatment Regimen Promising in Relapsed or Refractory Multiple Myeloma

Wayne Kuznar

Emerging Therapies

The addition of venetoclax, an oral selective small-molecule BCL-2 inhibitor, to bortezomib and dexamethasone resulted in impressive response rates in a phase 1b trial of patients with heavily pretreated relapsed or refractory multiple myeloma, said Cyrille Touzeau, MD, of Centre Hospitalier Universitaire de Nantes, France, who presented the trial’s results at ASCO 2016.

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Novel Chimeric Monoclonal Antibody Improves Survival in Advanced Gastric Cancers

Wayne Kuznar

Emerging Therapies

When added to standard chemotherapy, IMAB362, a chimeric monoclonal antibody against the claudin 18.2 protein, reduced the risks for disease progression and death by 50% compared with standard chemotherapy alone as first-line treatment for patients with advanced or recurrent gastric cancer and gastroesophageal junction carcinomas, according to data presented at ASCO 2016.

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Gene-Expression Signature Validated as Prognostic Marker in Stage II Colon Cancer

Alice Goodman

Personalized Medicine

A gene-expression signature assay called ColDx (Almac Diagnostics) successfully identified high-risk patients with stage II colon cancer who would benefit from chemotherapy, according to results of a new, prospective analysis of the previously published phase 3 Alliance C9581 clinical trial. For patients with stage I colon cancer, surgery is the treatment of choice, whereas for stage III disease, patients receive adjuvant chemotherapy. For patients with stage II disease, however, the best approach to the therapy has not been well-defined.

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Extending Letrozole Therapy Beyond 5 Years in Early Breast Cancer Reduces Recurrence

Phoebe Starr

Breast Cancer

Extending aromatase inhibitor therapy with letrozole for an additional 5 years beyond standard treatment with letrozole improved disease-free survival (DFS) and reduced the rate of new contralateral breast cancer in postmenopausal women with estrogen receptor (ER)-positive breast cancer. Prolonged letrozole did not improve overall survival. These were the main findings of the large MA.17R trial, which were presented at the plenary session at ASCO 2016.

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Three-Drug Regimen with Daratumumab a New Standard of Care for Relapsed or Refractory Multiple Myeloma

Wayne Kuznar

Multiple Myeloma

Adding the recently approved daratumumab (Darzalex), a human, CD38-directed monoclonal antibody, to a standard regimen of bortezomib (Velcade) and dexamethasone improved progression-free survival (PFS) by >60% compared with the standard regimen in patients with relapsed or refractory multiple myeloma, according to Antonio Palumbo, MD, Chief of the Multiple Myeloma Unit, University of Torino, Italy.

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Combination Immunotherapy Makes Progress in Advanced Melanoma

Phoebe Starr

Melanoma

Evidence is mounting that 2 immunotherapies are better than 1 as first-line treatment of patients with advanced melanoma. A phase 3 clinical trial showed that nivolumab plus ipilimumab was superior to ipilimumab or nivolumab alone, and a phase 1 trial suggests that pembrolizumab can be safely and effectively used in combination with other drugs as first-line treatment in this setting. Both studies were presented at ASCO 2016.

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Is the Glass Half Empty or Half Full? First Study Compares Robotic-Assisted Surgery and Open Radical Prostatectomy

Alice Goodman

Prostate Cancer

The first randomized trial to compare robotic-assisted prostatectomy with conventional open radical prostatectomy found no meaningful differences between these techniques in urinary and sexual function or in the rate of positive surgical margins in men with localized prostate cancer in the first 12 weeks after surgery (Yaxley JW, et al. Lancet. 2016 Jul 26. Epub ahead of print). The 24-month results will be published at a later time.

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Conference Correspondent – August 2016

Conference Correspondent

  • Cost-Effectiveness of Immune Checkpoint Inhibitors in NSCLC According to PD-L1 Expression
  • PD-L1 Expression and Outcomes with Pembrolizumab versus Docetaxel in Previously Treated NSCLC: KEYNOTE-010
  • Pembrolizumab plus Chemotherapy as Front-Line Therapy for Advanced NSCLC: KEYNOTE-021
  • Alectinib versus Crizotinib in ALK Inhibitor–Naïve, ALK Mutation–Positive NSCLC: The J-ALEX Study
  • Pembrolizumab plus Ipilimumab as Second-Line Therapy for NSCLC: KEYNOTE-021
  • TKIs in Advanced NSCLC Associated with Concomitant c-MET Overexpression and EGFR Mutations
  • Crizotinib in Advanced, MET Exon 14–Altered NSCLC
  • Vandetanib in Advanced, RET-Rearranged NSCLC: The Luret Study
  • Nivolumab versus Docetaxel in Advanced NSCLC: A 2-Year Update of CheckMate-017 and CheckMate-057
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The Challenge of Balancing Access to and Paying for New, High-Cost Cancer Therapies

James T. Kenney Jr, RPh, MBA

Payer's Perspective

Many significant and interesting topics highlighted at ASCO 2016 are discussed in this publication, covering clinical, safety, and economic issues related to cancer therapies. The challenge for health plans and other insurers is to balance the need to provide reasonable and appropriate patient access to new therapies and the ability to pay for them, because many new cancer treatments are designed for orphan diseases and are launched into the market at extremely high costs.

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