Immuno-Oncology

Adding atezolizumab to neoadjuvant standard of care therapy for HER2-positive early breast cancer did not result in a better pathologic complete response compared with placebo, according to findings from the phase 3 IMpassion050 trial.

The combination of anlotinib and sintilimab was found to provide a long-term survival benefit to patients with previously treated advanced cervical cancer.

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

Adding talimogene laherparepvec to pembrolizumab led to encouraging responses with a manageable safety profile in patients with advanced melanoma who progressed on prior anti–PD-1 therapy, most notably in the adjuvant setting, according to findings from the phase 2 MASTERKEY-115 trial.

The FDA has granted a fast track designation to PDS0101 for use in combination with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck cancer.

The PD-L1 antibody cosibelimab was found to elicit an encouraging objective response rate in patients with locally advanced cutaneous squamous cell carcinoma who were not eligible to undergo curative surgery or radiation.

New treatment strategies with immunotherapeutic agents are challenging standards of care and prolonging survival in first and later lines of metastatic urothelial carcinoma, metastatic renal cell carcinoma, and metastatic castration-resistant prostate cancer.

The combination of quavonlimab and pembrolizumab was found to be generally well tolerated and to have modest antitumor activity in patients with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor, according to data from a phase 1/2 trial (NCT03179436).

The approval of 2 nivolumab-containing combinations for patients with advanced or metastatic esophageal squamous cell carcinoma have opened the doors for immunotherapy to enter the landscape for this population allowing clinicians options to help patients to meet their individual treatment goals.

The combination of galinpepimut-S and nivolumab was found to extend survival in patients with malignant pleural mesothelioma who were either refractory to, or who had relapsed after, at least 1 line of standard therapy.

The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.

Highly effective tools, such as immunotherapeutic agents, have emerged for the treatment of patients with a wide range of malignancies.

Adjuvant pembrolizumab was found to result in a significant improvement in distant metastasis-free survival compared with placebo, with a continued reduction in risk of recurrence and an acceptable safety profile, in patients with resected stage IIB or stage IIC melanoma.

To date, oncologists have not seen much success with immunotherapy for neuroendocrine tumors.

Galinpepimut-S in combination with the PD-1 inhibitor pembrolizumab elicited a clinical benefit in patients with Wilms’ tumor-1-positive relapsed/refractory platinum-resistant advanced metastatic ovarian cancer, according to top line-line data from a phase 1/2 trial (NCT03761914).

The FDA has approved nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 status.

The FDA has lifted a partial clinical hold on the phase 1 NEON-2 trial investigating the use of davoceticept in combination with pembrolizumab in adult patients with advanced solid tumors or lymphoma.

The combination of nivolumab and axitinib achieved meaningful responses in treatment-naïve advanced renal cell carcinoma, according to results from a phase 1/2 trial (NCT03172754) presented at the 2022 Genitourinary Cancers Symposium.

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

Nicoletta Colombo, MD, PhD, discusses the practice-changing data to emerge from KEYNOTE-826 and the next steps for the pembrolizumab plus chemotherapy with or without bevacizumab regimen in patients with cervical cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

The combination of intratumoral vidutolimod and intravenous pembrolizumab demonstrated promising clinical activity in patients with PD-1 refractory melanoma.

Stereotactic body radiation therapy in combination with nivolumab and ipilimumab demonstrated clinically meaningful antitumor activity with a favorable toxicity profile in difficult-to-treat patients with refractory metastatic pancreatic cancer, although the contribution of SBRT is still unclear.

The combination of nivolumab plus ipilimumab was not found to significantly improve overall survival over standard-of-care chemotherapy when used in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma with a PD-L1 expression of 1% or higher.

According to longer follow-up data from the phase 3 CheckMate 274 trial, patients with high-risk, muscle-invasive urothelial carcinoma continued to experience clinically meaningful improvements in disease-free survival when treated with adjuvant nivolumab vs placebo.

The combination of sotigalimab and nivolumab elicited durable responses with a reasonable safety profile in patients with melanoma who were refractory to anti–PD-1 therapy, according to data from a phase 2 trial.

The combination of cabozantinib plus nivolumab demonstrated promising objective response rates in patients with non–clear cell renal cell carcinoma with prominent papillary features.

The addition of nivolumab to trastuzumab deruxtecan did not result in a marked clinical benefit in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

Igor Puzanov, MD, MSCI, FACP, discusses the adverse effects associated with immunotherapy and how to manage them.

The addition of pembrolizumab to chemotherapy led to significant survival benefits without substantial deterioration in health-related quality of life among patients with treatment-naïve, PD-L1–positive advanced triple-negative breast cancer according to results from the phase 3 KEYNOTE-355 trial.