Clinical

Videos

Marron discussed the primary objectives and early data from a phase 1 trial presented at the virtual AACR Annual Meeting regarding the neoantigen peptide vaccine, PGV-001.

Thomas Marron, MD, PhD, on the Safety, Feasibility, and Immunogenicity of Neoantigen Peptide Vaccine PGV-001

Articles

Indications for pembrolizumab, nivolumab, and atezolizumab are set for examination under the FDA’s Oncologic Drugs Advisory Committee for indications granted accelerated approval in breast, urothelial, gastric, and liver cancers.

Leading Anticancer Immunotherapeutics to Be Assessed for Continued Use for Indications Granted Accelerate Approval

Bellicum Pharmaceuticals, the developer of BPX-601, can now begin enrolling patients to their phase 1/2 trial again without modification to the study protocol.

FDA Lifts Clinical Hold on Phase 1/2 Trial Evaluating BPX-601 for Metastatic Pancreatic, Prostate Cancer

The phase 3 RATIONALE 302 trial demonstrated that compared to chemotherapy, tislelizumab showed a statistically significant and clinically meaningful improvement in overall survival in the intention-to-treat population of patients with advanced or metastatic esophageal squamous cell carcinoma.

Tislelizumab Improves OS Compared With Chemo in Advanced Unresectable or Metastatic ESCC

The increasing use of checkpoint inhibitors and other immunotherapies has created a need for the development of a cohesive education program and list of guidelines for treating common toxicities.

Aung Naing, MD, Discusses Strategies for the Effective Management of IRAEs

Though the majority of immune-related adverse events (irAEs) can be managed with corticosteroids and other immunosuppressive treatments, life-threatening and sometimes fatal events have still been reported thus revealing a need to develop measures for effective management.

Strategies Proposed to Improve Management of Immune-Related Adverse Events

The results demonstrated preliminary evidence of monotherapy activity, encouraging efficacy in combination with the PD-1 checkpoint inhibitor pembrolizumab (Keytruda), and biomarker data supporting FLX475’s mechanism of action.

Ongoing Phase 1/2 Trial of FLX475 Shows Promising Activity in Multiple Cancer Indications

The researchers hypothesized “that serum PD-L1 may identify a subgroup of patients with HER2-positive [metastatic breast cancer] who may benefit the most from the addition of novel immunotherapies to trastuzumab.”

Higher Serum PD-L1 Level Predicts Increased OS With Lapatinib vs Trastuzumab in CCTG MA.31 Study

Researchers suggested these findings may assist in better selection and prioritization of immune checkpoint inhibitor agents for testing in randomized clinical trials based on phase 2 single arm randomized clinical trial results.

6-Month PFS for 12-Month OS Model Appears Effective for Estimating 12-Month OS

This study found that the addition of immunotherapy to radiotherapy was associated with improved overall survival compared with radiotherapy alone in patients with brain metastases who received definitive surgery of the primary tumor site.

Immuno Oncology | Topics