Personalized Medicine

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

Chase Doyle

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

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

Chase Doyle

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

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

Phoebe Starr

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

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

Phoebe Starr

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

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

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

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

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

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

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

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

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

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

Phoebe Starr

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