Immuno-Oncology

Neoadjuvant treatment with the combination of nivolumab and ipilimumab led to responses and was well tolerated in patients with resectable hepatocellular carcinoma.

The Safety Monitoring Committee determined that prespecified criteria for pathologic complete response were met with the use of the PD-1 inhibitor tislelizumab alone or in combination with APL-1202 as neoadjuvant therapy in patients with muscle invasive bladder cancer.

James Chih-Hsin Yang, MD, PhD, discusses the implications of the phase 3 KEYNOTE-789 trial and what directions investigators can examine in the future to help fill the unmet need for patients with TKI-resistant, EGFR-mutated metastatic non–small cell lung cancer.

James L. Gulley, MD, PhD, reviews the safety and efficacy of PRGN-2009 alone and in combination with bintrafusp alfa in HPV-associated cancers and explains how this kind of approach may address an unmet clinical need.

Bernard Doger de Spéville, MD, PhD, discusses the investigation of eftilagimod alpha plus pembrolizumab in the TACTI-002 trial, including prior evidence supporting this approach, the trial’s design and primary objective, and the combination’s efficacy and safety in both the head and neck squamous cell carcinoma and non–small cell lung cancer cohorts.

Martin Cannon, PhD, details the history of investigating immune checkpoint inhibitors in patients with ovarian cancer and expands on the questions that need to be answered to potentially improve the activity of these agents in this patient population.

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.

The European Commission has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

The addition of pembrolizumab to COPDAC-28 consolidation may augment responses to treatment in pediatric and young adult patients with high-risk classical Hodgkin lymphoma who experience a slow early response to frontline chemotherapy.

The combination of pembrolizumab and lenvatinib demonstrated a statistically significant improvement in progression-free survival and objective response rate but failed to improve overall survival compared with pembrolizumab plus placebo as frontline therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

The combination of cabozantinib and atezolizumab led to a statistically significant improvement in progression-free survival compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer and measurable soft tissue disease following 1 prior novel hormonal therapy, meeting one of the primary end points in the primary analysis of the phase 3 CONTACT-02 trial.

Patients with mismatch repair–deficient and/or microsatellite instability metastatic colorectal cancer experienced a progression-free survival benefit with longer disease control following treatment with avelumab compared with standard second-line chemotherapy.

Treatment with the GVAX pancreatic cancer vaccine plus nivolumab and urelumab increased the presence of intratumoral activated cytotoxic T cells and showed early signs of efficacy in patients with resectable pancreatic adenocarcinoma.

Treatment with the long-acting interleukin-2 superkine led to durable tumor control and no dose-limiting toxicities in patients with advanced solid tumors, according to data from the dose-escalation portion of the phase 1/2 ABILITY-1 trial.

The PD-1 inhibitor pembrolizumab displayed activity with a manageable safety profile in patients with certain rare and ultra-raresarcoma histotypes.

Pembrolizumab produced sustained antitumor activity in patients with relapsed/refractory primary mediastinal large B-cell lymphoma, according to data from the final analysis of the phase 2 KEYNOTE-170 trial.

Pedro C. Barata, MD, MSc, discusses the importance of further exploring the facets of manipulating the microbiome to augment responses with immunotherapy in RCC, as well as the promise of the bifidogenic live bacterial product, CBM588.

Jonathan C. Trent, MD, PhD, discusses data from 2 phase 2 trials of immunotherapy in soft tissue sarcoma, as well as their clinical significance.

Amira Marouf, MD, PhD student, describes the nature of a comparative analysis conducted based on propensity score matching, and discussed the main takeaways regarding the efficacy of PD-1 inhibitors for patients with relapsed/refractory ENKTCL.

Neoadjuvant pembrolizumab plus chemotherapy led to an improvement in pathological complete response rate compared with chemotherapy plus placebo in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer.

Long-term data demonstrated that treatment with cosibelimab improved complete response rates over time in patients with locally advanced or metastatic cutaneous squamous cell carcinoma in a phase 1 trial.

The combination of mRNA-4157 and pembrolizumab will be further evaluated as an adjuvant treatment option for patients with resected, high-risk, stage IIB to IV melanoma in the phase 3 V940-001 trial.

Treatment with the combination of rivoceranib and camrelizumab led to a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib in previously untreated patients with unresectable hepatocellular carcinoma.

An evaluation of the utility of a cancer therapeutic in a clinical trial is determined through metrics that define 2 distinctive features of an antineoplastic strategy: efficacy and toxicity. Although that may be an oversimplification, the aim of such therapy is to improve clinical outcomes.

Omid Hamid, MD, discusses the key efficacy and safety findings for the combination of fianlimab plus cemiplimab in patients with advanced melanoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors have a PD-L1 combined positive score of at least 1.

Treatment with the combination of ENB-003 and pembrolizumab was well tolerated and produced preliminary signs of clinical activity in patients with platinum-refractory or -resistant, microsatellite stable ovarian cancer, and those with other advanced refractory solid tumors.

The addition of the PD-L1 inhibitor tislelizumab to standard bevacizumab and platinum-doublet chemotherapy in the first-line setting prolonged progression-free survival, produced encouraging responses, and was well tolerated in patients with cervical cancer.

The addition of pembrolizumab to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy, improved progression-free survival vs concurrent chemoradiotherapy alone in newly diagnosed patients with high-risk locally advanced cervical cancer.

The combination of the NOX1/4 inhibitor setanaxib and pembrolizumab produced progression-free survival benefits compared with placebo plus pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma.