Immuno-Oncology | Specialty

Cardio-oncology Specialists Pave Optimal Treatment Path for Patients With Cancer

August 4th 2021

The subspecialty of cardio-oncology has grown in recent years as improved cancer survival rates have expanded the population of long-term survivors with heightened risk of cardiovascular disease and drawn more attention to the need for preventive strategies and disease management.

FDA Grants Fast Track Status to Nemvaleukin Alfa for Mucosal Melanoma

August 2nd 2021

The FDA has granted a fast track designation to nemvaleukin alfa as a potential therapeutic option for patients with mucosal melanoma.

Adjuvant Nivolumab Approved in Europe for Select Esophageal or GEJ Cancers

July 30th 2021

The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.

Pembrolizumab Plus Chemo Significantly Improves OS in Metastatic TNBC With PD-L1 CPS ≥10

July 27th 2021

The addition of pembrolizumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial.

FDA Approves Pembrolizumab for High-Risk Early-Stage TNBC Plus Chemo as Neoadjuvant Treatment, Then as Single-Agent Adjuvant Treatment

July 27th 2021

The FDA has approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Roche Withdraws Application for Atezolizumab in Early or Locally Advanced TNBC in Europe

July 26th 2021

Roche Registration GmbH has withdrawn its application to extend the use of atezolizumab to the treatment of patients with early or locally advanced triple-negative breast cancer in Europe.

FDA Issues a Complete Response Letter for Retifanlimab for Squamous Cell Carcinoma of the Anal Canal

July 26th 2021

The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application for retifanlimab for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its present form.

Bristol Myers Squibb Withdraws Single-Agent Nivolumab Post-Sorafenib HCC Indication in the United States

July 24th 2021

Bristol Myers Squibb has decided to voluntarily withdraw the indication for nivolumab as a monotherapy for patients with hepatocellular carcinoma who were previously treated with sorafenib from the US market.

FDA Grants Regular Approval to Pembrolizumab Plus Lenvatinib for Advanced Endometrial Carcinoma

July 22nd 2021

The FDA has granted a regular approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.

FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma

July 21st 2021

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

Nivolumab/Ipilimumab Misses OS End Points in Frontline Head and Neck Cancer, But Shows Trend Toward Benefit in Subset

July 16th 2021

Nivolumab plus ipilimumab did not significantly improve overall survival over the EXTREME regimen in the frontline treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck, missing the primary end points of the phase 3 CheckMate-651 trial.

Neoadjuvant Pembrolizumab Combo Significantly Improves EFS in High-Risk Early-Stage TNBC

July 15th 2021

Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab was found to significantly improve event-free survival over neoadjuvant chemotherapy followed by adjuvant placebo in patients with high-risk, early-stage triple-negative breast cancer.

Atezolizumab/Bevacizumab Demonstrates Durable Efficacy in Advanced Malignant Peritoneal Mesothelioma

July 15th 2021

The combination of atezolizumab plus bevacizumab elicited encouraging, durable responses in patients with advanced malignant peritoneal mesothelioma, irrespective of tumor mutational burden and PD-L1 expression status.

Frontline Bempegaldesleukin/Nivolumab Continues to Elicit Durable Responses in Metastatic Melanoma

July 14th 2021

The combination of bempegaldesleukin plus nivolumab continued to produce promising antitumor activity with favorable tolerability when used in the frontline treatment of patients with metastatic melanoma, according to findings from a phase 2 cohort of the phase 1/2 PIVOT-2 trial.

Belapectin/Pembrolizumab Shows Early Activity, Tolerability in Metastatic Melanoma & Head and Neck Cancer

July 11th 2021

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma and head and neck cancer.

Emerging Immune Checkpoint Research Focuses on CD137

July 8th 2021

During the past decade, a growing number of PD-1/PD-L1 inhibitors gained FDA approval to treat a wide range of cancer types. Their stimulatory counterparts also emerged as sought-after anticancer targets but have proved much more challenging to manipulate therapeutically.

TIL Therapy LN-145 Elicits 21.4% ORR in Previously Treated Metastatic NSCLC

July 7th 2021

The tumor-infiltrating lymphocyte therapy LN-145 was found to induce an objective response rate of 21.4% in patients with advanced or metastatic non–small cell lung cancer who had progressed following systemic therapy.

Rigosertib/Nivolumab Combo Shows Early Potential in KRAS-Mutated NSCLC

July 6th 2021

The novel combination comprised of rigosertib and nivolumab showed preliminary evidence of potential anticancer activity in patients with advanced metastatic KRAS-mutated non–small cell lung cancer.

Pembrolizumab/Lenvatinib Regimen Being Tested in Advanced Gastroesophageal Adenocarcinoma

July 1st 2021

Frontline pembrolizumab plus lenvatinib, and chemotherapy is being tested against chemotherapy alone in patients with advanced gastroesophageal adenocarcinoma, as part of the international, 2-part, phase 3 LEAP-015 trial.

The Understanding of Immunotherapy Biomarkers Is Rapidly Evolving in Oncology

June 29th 2021

The landscape of immunotherapy biomarkers is rapidly evolving, and future developments are likely to have an impact on patients and clinicians alike.