Immuno-Oncology | Specialty

Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC

August 23rd 2022

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Durvalumab Plus Tremelimumab Elicits Favorable PFS Rates in Advanced Sarcomas

August 23rd 2022

The combination of durvalumab and tremelimumab demonstrated positive progression-free survival and overall survival rates with expected toxicity data in patients with advanced or metastatic soft tissue and bone sarcomas.

Perioperative Immunotherapy Demonstrates Promising pCR Rates in dMMR/MSI-H Gastric and GEJ Cancer

August 22nd 2022

Neoadjuvant nivolumab plus ipilimumab followed by adjuvant nivolumab elicited positive pathologic complete response rates in patients with locally advanced resectable mismatch repair–deficient and/or microsatellite instability–high gastric or gastroesophageal junction adenocarcinoma.

Immunotherapy Combinations Launch Into Earlier Lines and Signal Success in Metastatic Solid Tumors

August 17th 2022

Successful, established immunotherapies that have been approved for use in the metastatic setting are rapidly moving forward into the adjuvant and neoadjuvant settings, and novel agents are emerging in later lines.

Nivolumab/Ipilimumab Combo Provides Long-Term Survival Benefit in Advanced HCC After Sorafenib

August 13th 2022

The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.

FDA Approves VENTANA MMR RxDx To Identify dMMR Solid Tumors and as Companion Diagnostic for pMMR Endometrial Cancer

August 11th 2022

The FDA has expanded its approval of the VENTANA MMR RxDx panel to identify patients with mismatch repair–deficient solid tumors and as a companion diagnostic assay to determine eligibility for pembrolizumab as a treatment for patients with mismatch repair–proficient endometrial cancer.

Frontline Tislelizumab Proves Noninferior to Sorafenib for OS in Unresectable HCC

August 9th 2022

First-line treatment with tislelizumab was found to result in a noninferior overall survival benefit to that achieved with sorafenib in adult patients with unresectable hepatocellular carcinoma, meeting the primary end point of the phase 3 RATIONALE 301 trial.

Pembrolizumab/Lenvatinib Combo Misses Survival End Points in Unresectable HCC

August 3rd 2022

The addition of pembrolizumab to lenvatinib did not significantly improve overall survival or progression-free survival over lenvatinib alone when used in the frontline treatment of patients with unresectable hepatocellular carcinoma, missing the dual primary end points of the phase 3 LEAP-002 trial.

Eftilagimod Alpha/Pembrolizumab Combo Elicits Encouraging Survival Benefits in Anti–PD-1/PD-L1 Refractory NSCLC

August 2nd 2022

Eftilagimod alpha plus pembrolizumab demonstrated promising benefits in overall survival and progression-free survival as a second-line treatment in patients with non–small cell lung cancer who progressed on anti–PD-1/anti–PD-L1 therapy.

Subcutaneous Atezolizumab Produces Noninferior Pharmacokinetics Vs IV Atezolizumab in NSCLC

August 2nd 2022

The subcutaneous administration of atezolizumab produced non-inferior levels of the agent in the blood compared with intravenous atezolizumab in immunotherapy-naïve patients with locally advanced or metastatic non–small cell lung cancer who failed platinum-based chemotherapy.

Novel Biomarker Testing Could Enhance Immunotherapy Treatment Decisions in NSCLC

July 29th 2022

PD-L1 and tumor mutational burden are established biomarkers for leveraging immunotherapy in non–small cell lung cancer; however, their use may not be appropriate in determining treatment decisions for all patients.

Belantamab Mafodotin/Pembrolizumab Combo Elicits Favorable ORR in Heavily Pretreated Multiple Myeloma

July 26th 2022

The addition of pembrolizumab to belantamab mafodotin resulted in a higher overall response rate in patients with relapsed/refractory multiple myeloma than what has been observed with the antibody-drug conjugate alone, according to results from the phase 1/2 DREAMM-4 trial.

Pembrolizumab Post-Nephrectomy Extends Distant Metastasis-Free Survival, PFS2 in RCC

July 25th 2022

Toni K. Choueiri, MD, explains significant findings from the long-term efficacy analysis of the KEYNOTE-564 study and highlights the significance of these data for the field of RCC.

Immune Checkpoint Inhibitors at ASCO: Long-term Efficacy Data Mount

July 25th 2022

Twelve years after key research into immune checkpoint inhibitor therapy first made a splash at the American Society of Clinical Oncology Annual Meeting, evidence continues to mount that supports the durability of these agents in a range of cancers.

Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%

July 23rd 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab and relatlimab for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.

Pembrolizumab Plus Chemoradiation Misses EFS End Point in Head and Neck Squamous Cell Carcinoma

July 20th 2022

Pembrolizumab plus concurrent chemoradiation followed by pembrolizumab maintenance did not lead to a statistically significant improvement in event-free survival vs concurrent chemoradiation alone in patients with unresected locally advanced head and neck squamous cell carcinoma.

FDA Defers Action on BLA for Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma

July 14th 2022

The FDA has deferred action on the biologics license application seeking the approval of tislelizumab as a second-line treatment in patients with unresectable or metastatic esophageal squamous cell carcinoma, citing the inability to conduct required inspections in China because of travel restrictions associated with COVID-19.

Nivolumab Plus Ipilimumab Displays Durable Benefit in MSI-H/dMMR mCRC

July 8th 2022

Nivolumab alone or in combination with ipilimumab continued to demonstrate sustained clinical benefit as second- and first-line therapy, respectively, in patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.

Dostarlimab Produces Durable Responses With Acceptable Safety in dMMR Solid Tumors

July 8th 2022

Thierry André, MD, discusses the results of the phase 1 GARNET study with dostarlimab and the significance of these findings for patients with mismatch repair–deficient/microsatellite instqability–high solid tumors.

Durvalumab Plus Chemotherapy Improves pCR in Resectable NSCLC

June 30th 2022

Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.