Immuno-Oncology

The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

More patients with stage III non–small cell lung cancer received sequential chemoradiation and delayed the time to durvalumab treatment in a real-world setting compared with those enrolled on the phase 3 PACIFIC trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.

David C. Portnoy, MD, FACP, discusses ongoing studies examining immunotherapy and what is needed to move the needle forward in SCLC.

Namrata (Neena) Vijayvergia, MD, discusses the emerging role of immunotherapy in resectable and metastatic esophageal and gastric cancers, as well as key nuances that could complicate these agents’ utility in clinical practice.

The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.

The PD-L1 inhibitor atezolizumab was found to improve disease-free survival over best supportive care when used as an adjuvant treatment in patients with PD-L1–positive, stage II-IIIA non–small cell lung cancer, meeting the primary end point of the phase 3 IMpower010 trial.

Anthracyclines and taxanes remain a backbone in the early-stage setting of triple-negative breast cancer as further evaluations of immunotherapy in the neoadjuvant and adjuvant settings needs to be conducted—efforts that will continue to shape the treatment paradigm.

The combination of tilsotolimod plus ipilimumab failed to improve objective response rate over ipilimumab alone in patients with advanced melanoma who are refractory to a PD-1 inhibitor, missing the primary end point of the phase 2 ILLUMINATE-301 trial.

Edgardo Santos, MD, FACP, discusses advances made with immunotherapy regimens in the first-line treatment of patients with metastatic non–small cell lung cancer and areas of active investigation.

Richard S. Finn, MD, discusses the data with pembrolizumab and nivolumab that support their utility in hepatocellular carcinoma.

The European Commission has approved an expanded label for pembrolizumab for use as a single agent in the treatment of select adult and pediatric patients aged 3 years and older who have relapsed/refractory classical Hodgkin lymphoma.

Robert Wenham, MD, MS, FACOG, FACS, discusses the basis for combining chemotherapy, PARP inhibitors, and VEGF inhibitors with immunotherapy in ovarian cancer and ongoing research with ADCs in the field.

A phase 3 trial evaluating single-agent cemiplimab will be stopped early due to positive results demonstrating an overall survival benefit over chemotherapy in patients with recurrent or metastatic cervical cancer who previously received chemotherapy.

Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.

The field of triple-negative breast cancer is pushing to improve treatment by answering questions regarding biomarkers of response, defining the utility of neoadjuvant approaches, and exploring potential combinations with checkpoint inhibitors and PARP inhibitors.

Yelena Y. Janjigian, MD, discussed the promise of nivolumab plus chemotherapy in patients with PD-L1–positive advanced gastric cancer, GEJ cancer, and esophageal adenocarcinoma, as well as important biomarkers that should be used to guide sequencing decisions.

Treatment strategies for patients with advanced-stage non–small cell lung cancer have shifted away from platinum-based doublet chemotherapy and toward combination strategies that include immune checkpoint inhibitors.

Merck has withdrawn pembrolizumab from the US market for the treatment of patients with metastatic small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy and at least 1 previous line of treatment.

Immune therapy has evolved rapidly in multiple myeloma, and the field is on the verge of major improvements in outcomes.

February 26, 2021 - The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion to dostarlimab as a treatment for patients with recurrent or advanced microsatellite instability–high/mismatch repair deficient endometrial cancer who have progressed on or following platinum-based chemotherapy.

February 24, 2021 - The CAR T-cell product KTE-X19 continues to demonstrate durable clinical benefit in patients with relapsed/refractory mantle cell lymphoma, with an overall response rate of 92%.

Binod Dhakal, MD, discusses the potential impact of ide-cel, orva-cel, and cilta-cel in multiple myeloma therapy.

Aung Naing, MD, FACP, discusses potential immune-related adverse effects in oncology.

February 23, 2021 - AbbVie and Caribou Biosciences, Inc have entered into a collaboration and license agreement for the research and development of chimeric antigen receptory T-cell therapeutics.

ADP-A2M4CD8, a novel T-cell therapy, is being investigated in a range of tumor types that express MAGEA4, an antigen expressed in solid tumors that investigators say represents a promising target for cellular immunotherapy.

February 22, 2021 - The FDA has granted a fast track designation to the DNA-mediated interleukin-12 immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer.

Claud N. Grigg, MD, highlights different frontline combination regimens that are improving outcomes for patients with metastatic renal cell carcinoma.

AstraZeneca has voluntarily withdrawn durvalumab from the US market for the treatment of adult patients with locally advanced or metastatic bladder cancer.