Immuno-Oncology

The FDA has approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin in adult patients with locally advanced or metastatic biliary tract cancers.

The addition of vopratelimab to pimivalimab did not elicit a significant mean percent change of baseline tumor size in all measurable lesions vs pimivalimab alone in patients with immunotherapy-naïve, metastatic non–small cell lung cancer who were positive for the TISvopra predictive biomarker.

Several inroads have been made in the realm of gastrointestinal cancers, with novel immunotherapy combinations representing a significant advance spanning several tumor types.

The addition of talimogene laherparepvec to pembrolizumab did not significantly improve progression-free survival or overall survival over pembrolizumab alone in patients with advanced melanoma.

The addition of atezolizumab to vemurafenib and cobimetinib produced promising intracranial activity in patients with BRAF V600–mutated advanced melanoma and central nervous system metastases.

Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer who achieved a stable response to platinum-based chemotherapy.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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 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.

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 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.

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.