Immuno-Oncology | Specialty

Nivolumab/Ipilimumab Approved in Europe for Frontline PD-L1+ Advanced ESCC

April 5th 2022

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.

Nivolumab/Chemo Gets European Approval for Frontline PD-L1+ Advanced Esophageal Squamous Cell Carcinoma

April 5th 2022

The European Commission has approved nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher on tumor cells.

Second-Line Eftilagimod Alpha Plus Pembrolizumab Shows Promising Activity in Metastatic Lung Cancer

March 31st 2022

The combination of eftilagimod alpha and pembrolizumab was found to produce an encouraging early overall survival rate of 73% at the 6-month landmark when used as second-line treatment in patients with PD-1/PD-L1–refractory, metastatic non–small cell lung cancer, according to data from part B of the phase 2 TACTI-002 trial.

Tiragolumab Plus Atezolizumab/Chemo Misses PFS End Point in Extensive-Stage SCLC

March 30th 2022

The addition of the anti-TIGIT immunotherapy tiragolumab to atezolizumab plus carboplatin/etoposide failed to significantly improve progression-free survival over atezolizumab/chemotherapy alone when used in the frontline treatment of patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase 3 SKYSCRAPER-02 trial.

European Approval Sought for Neoadjuvant Nivolumab/Chemo in Resectable NSCLC

March 29th 2022

The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.

Pembrolizumab Plus Chemo With or Without Bevacizumab Approaches EU Approval for Select Cervical Cancer

March 28th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.

CHMP Moves to Recommend Pembrolizumab for MSI-H/dMMR Cancers

March 25th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.

James Allison, PhD, to Lead New Immunotherapy Unit at MD Anderson

March 24th 2022

James P. Allison, PhD, a Nobel Laureate and Giants of Cancer Care® award winner, will head up the new James P. Allison Institute at The University of Texas MD Anderson Cancer Center.

Concurrent Durvalumab/Chemoradiation Misses PFS End Point in Locally Advanced Cervical Cancer

March 24th 2022

Durvalumab given concurrently with chemoradiation was not found to significantly improve progression-free survival vs chemoradiation alone in patients with locally advanced cervical cancer, missing the primary end point of the phase 3 CALLA trial.

FDA Issues Complete Response Letter to Sintilimab/Chemo for Frontline Nonsquamous NSCLC

March 24th 2022

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Relatlimab/Nivolumab Combo Represents ‘Paradigm-Changing’ Advance in Metastatic Melanoma

March 24th 2022

Hussein A. Tawbi, MD, PhD, discusses the recent FDA approval of relatlimab/nivolumab in metastatic melanoma, the significance of the regulatory decision, and potential avenues for further exploration of the regimen.

Temozolomide Followed by Low-Dose Ipilimumab/Nivolumab Shows Potential in MSS and MGMT-Silenced mCRC

March 23rd 2022

Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.

FDA Approves Pembrolizumab for Select MSI-H/dMMR Advanced Endometrial Cancer

March 21st 2022

The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.

PRO Data Support the Use of Pembrolizumab Combo in Persistent, Recurrent, or Metastatic Cervical Cancer

March 19th 2022

Patient-reported outcome data support a favorable benefit/risk profile for the combination of pembrolizumab plus chemotherapy, with or without bevacizumab, in patients with persistent, recurrent, or metastatic cervical cancer.

FDA Grants Fast Track Status to 7HP349 for PD-1–Resistant Metastatic Melanoma

March 17th 2022

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

Guardant360 CDx Approved in Japan for Utilization in Advanced Solid Tumors

March 16th 2022

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

Relatlimab/Nivolumab Combo Continues to Impress in Previously Untreated Metastatic or Unresectable Melanoma

March 15th 2022

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

Phase 3 KEYLYNK-010 Trial Examining Pembrolizumab/Olaparib in mCRPC to Stop for Futility

March 15th 2022

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

Frontline Cabozantinib/Atezolizumab Does Not Improve OS Over Sorafenib in Advanced HCC

March 15th 2022

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

Frontline Bempegaldesleukin/Nivolumab Combo Misses Primary End Points in Unresectable or Metastatic Melanoma

March 14th 2022

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.