Value-Based Cancer Care Issues


August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights

View Additional ASCO 2019 Converage on AHDB

Avelumab plus Axitinib New First-Line Standard of Care in Advanced Renal-Cell Carcinoma

Chase Doyle

Renal-Cell Carcinoma

Chicago, IL—The results of a phase 3 clinical trial support the use of avelu­mab (Bavencio) plus axitinib (Inlyta) as a new first-line standard-of-care treatment for patients with newly diagnosed advanced renal-cell carcinoma. According to data presented at ASCO 2019, JAVELIN Renal 101 demonstrated longer progression-free survival (PFS) and higher overall response rates for the combination of avelumab with axitinib versus sunitinib (Sutent) monotherapy for treatment-naïve patients with advanced renal-cell carcinoma. The benefit was not limited only to the first-line setting. Patients who received avelumab plus axitinib also had longer PFS after second-line treatment and a longer mean duration of response than patients who received sunitinib alone. [ Read More ]

Access to Health Insurance Reduces Disparities in Cancer Care: The Case for the ACA

Phoebe Starr

Disparities in Oncology

Chicago, IL—Much has been written about racial disparities in cancer care and its outcomes, with some healthcare stakeholders proposing that there may be biological and/or socioeconomic differences that account for this disparity. However, a new study presented at ASCO 2019 suggests that the main explanation is simple—limited access to cancer care accounts for most of the disparity seen between African-American and white patients with cancer. [ Read More ]

Enzalutamide or Apalutamide Added to ADT Improves Outcomes in Hormone-Sensitive Prostate Cancer

Phoebe Starr

Prostate Cancer

Chicago, IL—Enzalutamide (Xtandi) and apalutamide (Erleada) had strong showings in 2 separate, randomized phase 3 clinical trials demonstrating that these drugs delay disease progression when added to background androgen-deprivation therapy (ADT) in ­patients with metastatic, hormone-sensitive prostate cancer. Both studies were presented at ASCO 2019 and were recently published in the New England Journal of Medicine. [ Read More ]

Polivy FDA Approved for Patients with Relapsed or Refractory DLBCL

FDA Approvals, News & Updates, Lymphoma

On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations. [ Read More ]

Xpovio Receives FDA Approval for Patients with Relapsed or Refractory Multiple Myeloma

FDA Approvals, News & Updates, Multiple Myeloma

On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-­CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation. [ Read More ]

Revlimid Approved for Patients with Follicular Lymphoma or Marginal-Zone Lymphoma

FDA Approvals, News & Updates, Lymphoma

On May 28, 2019, the FDA approved lenalidomide (Revlimid; Celgene), in combination with rituximab (Rituxan), for the treatment of patients with previously treated follicular lymphoma or marginal-zone lymphoma (MZL). The FDA used its priority review program for this approval, and granted lenalidomide plus rituximab an orphan drug designation for this new indication. [ Read More ]

Keytruda First PD-1 Inhibitor Approved as First-Line Monotherapy for Patients with Metastatic or Unresectable Head and Neck Cancer

FDA Approvals, News & Updates, Head and Neck Cancer

On June 10, 2019, the FDA approved pembrolizumab (Keytruda; Merck) as monotherapy or in combination with platinum and fluorouracil for the treatment of newly diagnosed patients with metastatic or unresectable recurrent head and neck squamous-cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1), as determined by an FDA-­approved test. The FDA reviewed the application for this new indication under its priority review program. [ Read More ]

Keytruda Receives New Indication for Metastatic Small-Cell Lung Cancer After Disease Progression

FDA Approvals, News & Updates, Lung Cancer

On June 17, 2019, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) monotherapy for the treatment of patients with metastatic small-cell lung cancer whose disease progressed during or after platinum-­based chemotherapy and at least 1 previous therapy. The FDA granted this application a priority review, making it the fifth FDA approval this year for pembrolizumab. [ Read More ]

Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for Patients with Multiple Myeloma Ineligible for Transplant

FDA Approvals, News & Updates, Multiple Myeloma

On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients. [ Read More ]

MONALEESA-7 Sets New Standard of Care for Premenopausal Advanced Breast Cancer: Adding CDK4/6 to Endocrine Therapy Extends Survival

Phoebe Starr

Breast Cancer

Chicago, IL—The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib (Kisqali) to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial presented at ASCO 2019. [ Read More ]

Practice-Changing Results: Olaparib Maintenance Therapy Extends Progression-Free Survival in Metastatic Pancreatic Cancer with Germline BRCA Mutation

Phoebe Starr

Pancreatic Cancer

Chicago, IL—Maintenance therapy with the targeted drug olaparib (Lynparza) after first-line platinum-based chemotherapy prolonged progression-­free survival (PFS) in patients with metastatic pancreatic cancer and a germ­line BRCA mutation, according to results of the phase 3 POLO clinical trial presented at the plenary session at ASCO 2019. Lead investigator Hedy L. Kindler, MD, FASCO, Medical Director, Gastrointestinal Oncology, University of Chicago Medicine, IL, presented the results. [ Read More ]

Patient Navigators, Clinician Education Can Remove Barriers to Enrollment in Clinical Trials

Chase Doyle

Value-Based Care

Chicago, IL—Fewer than 7% of adults with cancer and even fewer minority patients participate in clinical trials, which negatively affects the ability to determine the safety and efficacy of new and investigational therapies. At ASCO 2019, 2 experts discussed strategies to overcome the barriers to clinical trial participation and to help enroll more patients with cancer in them. [ Read More ]

FDA Unveils Oncology-Specific “Project Facilitate,” Expanding Access to Investigational Cancer Drugs

Phoebe Starr

Value-Based Care

Chicago, IL—At ASCO 2019, the FDA announced an oncology-specific pilot program for physicians and patients who are seeking access to investigational therapies. The expanded access pilot program is a concierge service, said Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, who spoke at a press conference where the new program—Project Facilitate—was announced. [ Read More ]

Overcoming Current Barriers to Using CAR T-Cell Therapy in the Community Setting

Chase Doyle

Immunotherapy

Chicago, IL—With 475 cell and gene therapy companies in North America representing a business enterprise with approximately $20 billion, new immunotherapies are moving rapidly from the laboratory to the clinic. As chimeric antigen receptor (CAR) T-cell therapy makes its way from the academic to community setting, however, appropriate resources and infrastructure are required to ensure the safe and effective management of patients. [ Read More ]

Applying CAR T-Cell Therapies to Solid Tumors: Overcoming Current Challenges

Chase Doyle

Immunotherapy

Chicago, IL—Reprogramming patients’ immune cells to treat their cancer has become the front line of cancer therapy, with chimeric antigen receptor (CAR) T-cell therapy now approved by the FDA for several blood cancers. But translating this success to solid tumors remains a challenge. At ASCO 2019, ­Gianpietro Dotti, MD, Cancer Cellular Immunotherapy Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, discussed efforts to extend the application of CAR T-cell therapy to solid tumors [ Read More ]

Autologous Mesothelin-Targeted T-Cells Induce Responses in Pleural Solid Tumors

Wayne Kuznar

Emerging Therapies

Chicago, IL—A mesothelin-targeted chimeric antigen receptor (CAR) T-cell immunotherapy demonstrated encouraging antitumor activity in combination with pembrolizumab in patients with mesothelin-associated malignant pleural solid tumors, primarily mesothelioma, who had disease progression after platinum-containing chemotherapy, according to results presented at ASCO 2019. [ Read More ]

Enfortumab Vedotin Promising Third-Line Option for Metastatic Urothelial Cancer

Phoebe Starr

Emerging Therapies

Chicago, IL—Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at ASCO 2019. [ Read More ]

Larotrectinib Has Wide-Ranging Efficacy in Advanced Solid Tumors with NTRK Gene Fusion

Wayne Kuznar

Biomarkers

Chicago, IL—In 2018, larotrectinib (Vitrakvi) became the first drug to be approved by the FDA as a tumor-agnostic therapy based solely on the presence of a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation TRK fusion biomarker. Several analyses presented at ASCO 2019 confirm the wide-ranging efficacy of larotrectinib in pediatric and adult patients with advanced cancer and NTRK gene fusion cancer, as well as those whose tumor involves the central nervous system (CNS). [ Read More ]

Fixed-Duration Targeted Therapy with Venetoclax plus Obinutuzumab New Front-Line Standard for Patients with Chronic Lymphocytic Leukemia

Phoebe Starr

Leukemia

Chicago, IL—In the phase 3 CLL14 trial, fixed-duration therapy with the combination of venetoclax (Venclexta) plus obinutuzumab (Gazyva) was superior to the combination of chemotherapy with chlorambucil plus obinutuzu­mab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. Kirsten Fischer, MD, Center for Integrated Oncology Cologne-Bonn, University Hospital, Germany, presented the study results at ASCO 2019 and were published simultaneously (Fischer K, et al. N Engl J Med. 2019;380:2225-2236). [ Read More ]

New Triple-Drug Regimen for Newly Diagnosed Patients with Multiple Myeloma

In the Literature, Multiple Myeloma

Until recently, patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT), the multiagent regimen with lenalidomide (Revlimid) and dexamethasone was the standard of care. Results of the prespecified interim analysis of the MAIA trial demonstrated the benefit of adding daratumumab (Darzalex) to this combination therapy (Facon T, et al. N Engl J Med. 2019;380:2104-2115). Based on the results of this study, on July 1, 2019, the FDA approved this triple-drug regimen for use in this patient population. [ Read More ]

Long-Term Outcomes Affect Cost-Effectiveness of CAR T-Cell Therapy for DLBCL

In the Literature, Lymphoma

The 2 chimeric antigen receptor (CAR) T-cell therapies available so far—axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah)—may be considered cost-effective treatments for adults with diffuse large B-cell lymphoma (DLBCL), depending on the long-term outcomes of these patients, according to a recent cost-effective analysis (Lin JK, et al. J Clin Oncol. 2019 Jun 3. Epub ahead of print). [ Read More ]

Gilteritinib and CX-01 in the Treatment of Patients with Acute Myeloid Leukemia

Phoebe Starr

Leukemia

Chicago, IL—Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and FLT3-ITD allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib. [ Read More ]

Combination Immune Blockade Promising in High-Grade Neuroendocrine Tumors: The DART “Basket” Clinical Trial

Phoebe Starr

Neuroendocrine Tumors

Atlanta, GA—In a phase 2 “basket” clinical trial, the combination of ipilimu­mab (Yervoy), a CTLA-4 inhibitor, and nivolumab (Opdivo), a PD-1 inhibitor, led to tumor shrinkage in 44% of patients with rare, aggressive, extrapancreatic high-grade neuroendocrine tumors (NETs), and the responses were durable. No responses were seen in low-grade tumors. These results come from the Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) study, which was presented at the 2019 American Association for Cancer Research annual meeting, by Sandip P. Patel, MD, DART Clinical Study Chair, and Deputy Director, San Diego Center for Precision Immunotherapy, Moores Cancer Center, UC San Diego Health, La Jolla, CA. [ Read More ]