Immuno-Oncology | Specialty

FDA Issues Complete Response Letter for Neoadjuvant Pembrolizumab for High-Risk TNBC

March 29th 2021

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.

Adjuvant Nivolumab Takes Step Toward EU Approval in Muscle-Invasive Urothelial Carcinoma

March 29th 2021

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.

Durvalumab Use Differs in Real-World, PACIFIC Stage III NSCLC Populations

March 27th 2021

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.

EU Panel Recommends Atezolizumab for Frontline PD-L1–High Metastatic NSCLC

March 26th 2021

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.

Portnoy Previews Immunotherapy Breakthroughs Shaking Up Frontline SCLC Paradigm

March 24th 2021

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

Immunotherapy Makes Waves in Gastroesophageal and Gastric Cancers

March 24th 2021

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.

FDA Approves Pembrolizumab for Advanced Esophageal or GEJ Cancer

March 22nd 2021

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.

Atezolizumab Improves DFS Over BSC in PD-L1+ Resectable, Early-Stage NSCLC

March 22nd 2021

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.

Chemo Reigns Control in Early-Stage TNBC, But Immunotherapy, ADCs Gain Ground in Metastatic Setting

March 20th 2021

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.

Tilsotolimod/Ipilimumab Fails to Improve ORR in PD-1 Refractory, Advanced Melanoma

March 19th 2021

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.

Santos Spotlights Success With Checkpoint Inhibition in Frontline Metastatic NSCLC

March 18th 2021

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.

As FDA Review Approaches, Finn Reflects on the Utility of Pembrolizumab, Nivolumab in HCC

March 17th 2021

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

Pembrolizumab Approved in Europe for Adult and Pediatric Relapsed/Refractory Classical Hodgkin Lymphoma

March 17th 2021

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.

Immunotherapy Research Instigates More Questions Than Answers in Ovarian Cancer

March 15th 2021

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.

Cemiplimab Phase 3 Trial Stopped Early Due to OS Benefit in Advanced Cervical Cancer

March 15th 2021

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.

FDA Will Reassess 6 Immunotherapy Accelerated Approvals

March 12th 2021

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.

Checkpoint and PARP Inhibition Remain the Focus of Ongoing Research in TNBC

March 10th 2021

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.

Frontline Nivolumab Plus Chemo Shows Practice-Changing Potential in GI Cancers

March 5th 2021

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.

Frontline ICI Therapy Gains Traction Across NSCLC Settings

March 4th 2021

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 Withdraws Pembrolizumab Metastatic SCLC Indication in the United States

March 2nd 2021

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.