Immuno-Oncology | Specialty

Agenus Withdraws BLA for Balstilimab in Metastatic Cervical Cancer

October 22nd 2021

The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC

October 22nd 2021

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

FDA Approves Companion Diagnostic for Adjuvant Atezolizumab in Stage II to IIIA NSCLC

October 22nd 2021

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

Nivolumab/Chemo Approved in Europe for HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

October 21st 2021

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

Chemoimmunotherapy Combos, Adjuvant Approaches and Bispecifics Are Among Exciting Advances in Lung Cancer

October 19th 2021

The availability of chemoimmunotherapy combinations and targeted agents for common and rare mutations alike in non–small cell lung cancer has fostered discussions that might have been unthinkable just a decade or so ago.

Pembrolizumab/Lenvatinib Approaches EU Approval for Select RCC and Endometrial Carcinoma

October 15th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding approval of the combination of pembrolizumab and lenvatinib for 2 indications: select patients with renal cell carcinoma and select patients with endometrial carcinoma.

Dr. Johnson on the Promise of DS-7300 in SCLC and Other Advanced Solid Tumors

October 13th 2021

Melissa L. Johnson, MD, discusses the promise of DS-7300 in small cell lung cancer and other advanced solid tumors.

IO Combo Anchors a New Front Line Taking Shape in Unresectable HCC

October 13th 2021

The tide is starting to turn toward more effective frontline systemic therapies for patients with unresectable hepatocellular carcinoma as a result of the introduction of a novel immune-oncology combination.

Nivolumab/Cabozantinib Continues to Showcase Deep, Durable Responses in Advanced RCC

October 11th 2021

Nivolumab plus cabozantinib continued to significantly improve overall response rate vs sunitinib in patients with previously untreated, advanced renal cell carcinoma, with meaningful response outcomes observed irrespective of dose modifications with cabozantinib and fewer responders in the doublet arm requiring subsequent treatment.

Lenvatinib Plus Pembrolizumab Makes an Impression in Advanced RCC

October 6th 2021

Robert J. Motzer, MD, spoke about the “exceptional” efficacy of the combination and how it fits into the evolving RCC treatment landscape.

Cemiplimab/Chemo Represents New Frontline Option for Advanced NSCLC Without Actionable Mutations

October 4th 2021

Miranda Gogishvili, MD, discusses the rationale for examining cemiplimab plus platinum-doublet chemotherapy as a frontline treatment in patients with advanced NSCLC and key findings from the phase 3 EMPOWER-Lung 3 trial.

Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA

October 1st 2021

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Frontline Pembrolizumab/Chemo Represents New Standard in Metastatic TNBC With PD-L1 CPS ≥10

September 28th 2021

Hope S. Rugo, MD, discusses the final data from the phase 3 KEYNOTE-355 trial with pembrolizumab plus chemotherapy in patients with metastatic TNBC and the clinical impact on the treatment paradigm.

Pembrolizumab Plus BSC Improves OS in Advanced HCC Previously Treated With Sorafenib

September 27th 2021

The addition of pembrolizumab to best supportive care resulted in a statistically significant improvement in overall survival vs BSC alone in Asian patients with advanced hepatocellular carcinoma who previously received treatment with sorafenib, meeting the primary end point of the phase 3 KEYNOTE-394 trial.

FDA Approval Sought for Frontline Nivolumab Plus Ipilimumab or Chemo in Advanced ESCC

September 27th 2021

The FDA has accepted the supplemental biologics license applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy in the frontline treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Janjigian Spotlights Significance of Nivolumab/Chemo Approval for Frontline Gastric Cancer

September 24th 2021

Yelena Y. Janjigian, MD, further discusses the clinical significance of the FDA approval of nivolumab plus chemotherapy in the frontline treatment of patients with gastric cancer.

Dietrich Details Data and Future Research With Immunotherapy in Stage III NSCLC

September 20th 2021

Dr. Dietrich discusses the latest developments with immunotherapy and targeted therapy in stage III non–small cell lung cancer.

FDA Grants Priority Review to Relatlimab/Nivolumab for Unresectable or Metastatic Melanoma

September 20th 2021

The FDA has granted priority review to a biologics license application for the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients aged 12 years and older and weighing at least 40 kg who have unresectable or metastatic melanoma.

Frontline Nivolumab/Ipilimumab Maintains OS Benefit Across Subgroups in Unresectable Malignant Pleural Mesothelioma

September 17th 2021

The frontline combination of nivolumab and ipilimumab continued to demonstrate improved overall survival across subgroups compared with standard chemotherapy at 3 years in patients with unresectable malignant pleural mesothelioma.

Pembrolizumab/Chemo Nears EU Approval for Select TNBC With PD-L1 CPS ≥10

September 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.