Immuno-Oncology | Specialty

FDA Approves Adjuvant Nivolumab for Completely Resected Stage IIB/C Melanoma

October 14th 2023

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

CHMP Recommends First-Line Pembrolizumab Plus Chemotherapy for PD-L1+, HER2– Advanced Gastric/GEJ Adenocarcinoma

October 13th 2023

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.

TJ-L14B/ABL503 Showcases Early Efficacy Signals in Advanced or Metastatic Solid Tumors

October 10th 2023

TJ-L14B/ABL503 demonstrated preliminary efficacy signals in the form of responses in patients with progressive, locally advanced or metastatic solid tumors who were relapsed or refractory after previous lines of therapy.

Perioperative Pembrolizumab Meets Dual Primary End Point of OS in NSCLC

October 10th 2023

Pembrolizumab plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting, significantly improved overall survival vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer, meeting the dual primary end point of the phase 3 KEYNOTE-671 trial.

Dr Aerts on the Rationale for the DENIM Trial in Mesothelioma

October 5th 2023

Joachim G. J. V. Aerts, MD, PhD, discusses the rationale for conducting the phase 3 DENIM trial in patients with mesothelioma, highlighting the importance of focusing investigational efforts onto the dendritic cells.

Adjuvant Pembrolizumab Improves DFS in Localized Urothelial Cancer

October 5th 2023

Pembrolizumab as adjuvant therapy led to a statistically significant and clinically meaningful improvement in disease-free survival compared with observation in patients with localized muscle invasive urothelial cancer and locally advanced urothelial cancer.

NT219 Plus Cetuximab Elicits Responses, Demonstrates Tolerability in Recurrent or Metastatic HNSCC

October 3rd 2023

Second-line treatment with NT219 alone and in combination with cetuximab demonstrated safety and tolerability, and the combination produced confirmed partial responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

PDS0101 Plus Pembrolizumab Elicits 74% 2-Year OS Rate in ICI-Naïve, HPV16+ HNSCC

October 3rd 2023

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

Immunotherapy Combinations Deliver Outcome-Shifting Responses in Lymphoma

October 3rd 2023

Immunotherapy has become a valuable tool for the treatment of patients with various types of lymphomas because of its ability to specifically target cancer cells, particularly those in blood cancers.

Pembrolizumab/Lenvatinib Regimens Miss Survival End Points in Metastatic NSCLC

September 22nd 2023

The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.

Enfortumab Vedotin Plus Pembrolizumab Generates Survival Benefit in Previously Untreated Advanced Urothelial Cancer

September 22nd 2023

Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.

Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC

September 22nd 2023

Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.

Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy

September 19th 2023

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Neoadjuvant Nivolumab/Ipilimumab Combo Elicits Responses, Safety in Resectable HCC

September 13th 2023

Neoadjuvant treatment with the combination of nivolumab and ipilimumab led to responses and was well tolerated in patients with resectable hepatocellular carcinoma.

Preoperative APL-1202 Plus Tislelizumab Meets pCR Criteria, Moves to Next Stage of Trial in MIBC

September 13th 2023

The Safety Monitoring Committee determined that prespecified criteria for pathologic complete response were met with the use of the PD-1 inhibitor tislelizumab alone or in combination with APL-1202 as neoadjuvant therapy in patients with muscle invasive bladder cancer.

Dr Myall on Immunotherapy Doublets and Chemoimmunotherapy in NSCLC

September 8th 2023

Nathaniel Myall, MD, clinical assistant professor, medicine - oncology, Stanford Medicine, discusses efficacy findings from 3 clinical trials investigating combination immunotherapy and chemoimmunotherapy treatment approaches in patients with non–small cell lung cancer.

Subgroup Observations From Missed KEYNOTE-789 Data in NSCLC Provide Insight for the Future

September 4th 2023

James Chih-Hsin Yang, MD, PhD, discusses the implications of the phase 3 KEYNOTE-789 trial and what directions investigators can examine in the future to help fill the unmet need for patients with TKI-resistant, EGFR-mutated metastatic non–small cell lung cancer.

PRGN-2009 Plus Bintrafusp Alfa Shows Early Activity in HPV-Associated Malignancies

September 3rd 2023

James L. Gulley, MD, PhD, reviews the safety and efficacy of PRGN-2009 alone and in combination with bintrafusp alfa in HPV-associated cancers and explains how this kind of approach may address an unmet clinical need.

TACTI-002 Data Show Antitumor Activity With Second-Line Eftilagimod Alpha and PD-1 Inhibition in HNSCC

September 1st 2023

Bernard Doger de Spéville, MD, PhD, discusses the investigation of eftilagimod alpha plus pembrolizumab in the TACTI-002 trial, including prior evidence supporting this approach, the trial’s design and primary objective, and the combination’s efficacy and safety in both the head and neck squamous cell carcinoma and non–small cell lung cancer cohorts.