Value-Based Cancer Care Issues


April 2019, Vol 10, No 2

Atezolizumab plus Nab-Paclitaxel for Triple-Negative Breast Cancer with PD-L1 Expression

Phoebe Starr

Breast Cancer

San Antonio, TX—Adding the PD-L1 inhibitor atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) chemother­apy is the first immunotherapy-based combination to improve progression-free survival (PFS) and overall survival (OS) in women with advanced or metastatic triple-negative breast cancer and PD-L1 expression compared with placebo plus nab-paclitaxel, according to results of the IMpassion130 clinical trial. [ Read More ]

Personalizing Immunotherapy in NSCLC Using PD-L1 and Tumor Mutation Burden as Biomarkers

Wayne Kuznar

Immunotherapy, Lung Cancer

San Francisco, CA—Tumor expression of PD-L1 has consistently predicted ­response and survival outcomes in non–small-cell lung cancer (NSCLC), whereas the role of PD-L1 in immune cells is unclear, said Edward B. Garon, MD, Director, Thoracic Oncology Program, David Geffen School of Medicine, University of California, Los Angeles, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. [ Read More ]

Imbruvica plus Gazyva Approved as First-Line Treatment for CLL/SLL

FDA Approvals, News & Updates

On January 28, 2019, the FDA approved the combination of the oral Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica; Pharmacyclics), plus the CD20-directed cytolytic antibody obinutuzumab (Gazyva; Genentech), for the treatment of adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Imbruvica was already approved as a single agent for different indications, including for adults with CLL or SLL, with or without 17p deletion. [ Read More ]

Lonsurf Approved for Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

FDA Approvals, News & Updates

On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy. The FDA used its priority review process for this new indication and granted it an orphan drug designation. Trifluridine plus tipiracil was previously approved for metastatic colorectal cancer. [ Read More ]

Herceptin Hylecta a New Subcutaneous Injection Approved for Patients with HER2-Positive Breast Cancer

Breast Cancer, FDA Approvals, News & Updates

On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality an­thracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. This SC injection is a new formulation of intravenous (IV) trastuzumab. [ Read More ]

Tecentriq plus Abraxane for Advanced or Metastatic Triple-Negative Breast Cancer with PD-L1 Expression

FDA Approvals, News & Updates

On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC. [ Read More ]

Immunotherapy Strategies in the Updated NCCN Guideline for NSCLC Hinge on PD-L1 Testing

Wayne Kuznar

2019 NCCN Conference

Orlando, FL—The updated National Comprehensive Cancer Network (NCCN) guideline for non–small-cell lung cancer (NSCLC; version 3.2019) is focused on improving patient outcomes with immunotherapy. Pembrolizumab (Keytruda) is recommended as the preferred first-line immune checkpoint inhibitor for patients with ≥50% of tumor cells that express PD-L1. First-line immunother­apy is restricted to NSCLC without EGFR or ALK mutations. [ Read More ]

Updated NCCN Breast Cancer Guideline Expands Treatment Recommendations for HR-Positive, HER2-Negative Disease

Wayne Kuznar

2019 NCCN Conference, Breast Cancer

Orlando, FL—Options for the treatment of patients with advanced hormone receptor (HR)-positive, HER2­negative breast cancer are expanding. The updated National Comprehensive Cancer Network (NCCN) guideline (version 1.2019) for the management of invasive breast cancer is focused on HR-positive, HER2-negative disease. William J. Gradishar, MD, Director, Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, discussed the updated guideline at the NCCN 2019 Conference. [ Read More ]

First-Line Pembrolizumab plus Axitinib Combination Boosts Survival in Metastatic Renal-Cell Carcinoma

Phoebe Starr

Genitourinary Cancers Symposium

San Francisco, CA—First-line therapy with pembrolizumab (Keytruda) plus ­axitinib (Inlyta) significantly improved overall survival (OS), progression-free survival (PFS), and objective response rates compared with standard-of-care sunitinib (Sutent) in patients with clear-cell metastatic renal-cell carcinoma (RCC) in KEYNOTE-426. The combination of pembrolizumab plus axitinib achieved a significant 47% reduction in mortality risk versus sunitinib (P <.0001). [ Read More ]

Tamoxifen 5 mg Daily as Effective as 20 mg in Early Localized Breast Cancer

Phoebe Starr

Breast Cancer

San Antonio, TX—The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo. [ Read More ]

Adjuvant Chemotherapy May Be Spared in Localized Breast Cancer If pCR Is Attained with Neoadjuvant Chemotherapy

Phoebe Starr

Breast Cancer

San Antonio, TX—Reaching pathologic complete response (pCR) after neo­adjuvant chemotherapy correlates with significantly improved event-free survival (EFS) and overall survival (OS) in patients with localized breast cancer, according to results of a large comprehensive meta-analysis presented at the 2018 San Antonio Breast Cancer Symposium. [ Read More ]

CAR T-Cell Therapy Associated with Unique, Acute Adverse Events Requiring Vigilant Monitoring

Wayne Kuznar

Immunotherapy

San Francisco, CA—Chimeric antigen receptor (CAR) T-cell therapy is associated with unique adverse events that require vigilant monitoring, aggressive care, and specialized management. Marco L. Davila, MD, PhD, Medical Oncologist, Blood and Marrow Transplant and Cellular Immunotherapy Program, Moffitt Cancer Center, Tampa, FL, provided an overview of this topic at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. [ Read More ]

Adjuvant Therapy with Durvalumab Shows Promise in Advanced Esophageal Cancer

Wayne Kuznar

GI Cancers Symposium

San Francisco, CA—Adjuvant treatment with durvalumab (Imfinzi), a checkpoint inhibitor, in patients with residual disease after trimodal therapy for advanced esophageal or gastroesophageal junction (GEJ) adeno­carcinoma was associated with a 79% 1-year relapse-free survival rate in a phase 2 clinical trial. Historically, the 1-year relapse rate has been 50% in patients with GEJ carcinoma who do not achieve a pathologic complete response with trimodal therapy, even with additional chemotherapy, said Hirva Mamdani, MD, Thoracic Oncology, Karmanos Cancer Institute/Wayne State University, Detroit, MI, at the 2019 Gastrointestinal Cancers Symposium. [ Read More ]

Triple-Drug Regimen Improves Survival in Metastatic Colorectal Cancer with BRAF V600E Mutation

Wayne Kuznar

GI Cancers Symposium

San Francisco, CA—Updated results from the safety lead-in of the phase 3 BEACON CRC clinical trial show a mature median overall survival (OS) of 15.3 months with the triple-drug regimen of encorafenib (Braftovi), a BRAF inhibitor; binimetinib (Mektovi), a MEK inhibitor; and cetuximab (Erbitux), an EGFR inhibitor, for the treatment of patients with metastatic colorectal cancer (CRC) and BRAF V600E mutation. [ Read More ]

SM-88, a Novel Tumor Metabolism–Altering Regimen, Shows Promise as Third-Line Therapy for Metastatic Pancreatic Cancer

Wayne Kuznar

GI Cancers Symposium

San Francisco, CA—Increased understanding of tumor genetics and tumor metabolism has led to improved therapies for cancer. The impact of cancer metabolism on tumor pathways is particularly important in pancreatic cancer. A novel tumor metabolism–altering oral drug known as SM-88 combines the investigative tyrosine derivative (D,L-alpha-metyrosine) with 3 repurposed agents—an mTOR inhibitor (sirolimus), a CYP3A4 inducer (phenyt­oin), and an oxidative stress catalyst (methoxsalen). [ Read More ]

Strategic Insights on Midsize Employers and Cancer Care Coverage

Bincy Augustine, PharmD; F. Randy Vogenberg, PhD, RPh, FASHP

Employers’ Perspective

It is no surprise that healthcare costs are at an all-time high and continue to take center stage in political, social, and economic debates. Employers, as health plan sponsors and as purchasers of care, are looking to take matters into their own hands and tackle the problem through innovative reimbursement strategies. Not all employers, however, are built the same. Experiences in controlling healthcare costs vary between small and large employers. The most affected employers are in the middle and are known as midsize employers. [ Read More ]

Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Cancer

Breast Cancer, FDA Approvals, News & Updates

On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin. [ Read More ]