The American Society of Clinical Oncology’s ASCO20 Virtual Scientific Program will feature abstracts from three Hoosier Cancer Research Network studies. The program, taking place May 29-31, will feature more than 250 oral abstract presentations and 2,500 poster presentations from 24 disease-based and specialty tracks.

The abstracts featuring HCRN studies include an oral abstract for GU16-260, a poster discussion for GU14-188, and posters for GU14-188 and LUN14-179.
 

GU16-260 Oral Abstract

The GU16-260 virtual oral abstract, titled “Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260),” provides data concerning the efficacy of single-agent nivolumab as frontline therapy for patients with metastatic clear cell renal cell carcinoma (ccRCC) as well as data on the extent to which patients failing to respond to nivolumab could have response salvaged with the addition of ipilimumab, said Michael B. Atkins, MD, of Georgetown Lombardi Comprehensive Cancer Center. The multi-institution study, led by Dr. Atkins, is currently open to accrual.

“The results show that nivolumab has about a 30% response rate (RR) in patients with ccRCC which is greater than the 25% RR observed in patients who had prior VEGFR TKI therapy,” Dr. Atkins said. “Activity was seen across all IMDC groups with the highest response rate (15 of 30, or 50%) seen in the IMDC favorable risk group. Overall response rates of 25% were seen in each of the IMDC intermediate and poor risk groups.

“The study shows that 13% of those who were able to receive ipilimumab boost — due to protocol constraints such as the requirement for a biopsy showing viable tumor, only about one-half of those exhibiting disease progression on nivolumab monotherapy were eligible to receive the ipilimumab boost as part of this study,” Dr. Atkins said. “This suggests that nivolumab monotherapy could be an option for patients with favorable risk disease, where the ability to give subsequent treatments would not be compromised, or in those in whom the addition of ipilimumab or a VEGFR TKI is considered risky, e.g., for those who are frail or have a history of autoimmune disease and/or cardiovascular disease, but supports the use of immunotherapy-based combinations, such as nivolumab/ipilimumab, as a front-line therapy immunotherapy combination in those perceived to be able to tolerate it.”

Dr. Atkins said additional studies will help identify the mechanisms of resistance to nivolumab, which may aid in biomarker and rationale combination therapy development.

See abstract.
 

LUN14-179 Poster

The LUN14-179 poster reported on the association between immune-related adverse events (irAEs) and efficacy outcomes with consolidation pembrolizumab after chemoradiation in patients with stage III NSCLC: an analysis from HCRN LUN14-179.

In earlier abstracts, LUN14-179 investigators found that adding pembrolizumab to chemotherapy and radiation improved the time to metastatic disease, improved progression-free survival, and likely improved overall survival. These findings were consistent with those from a large international phase III study that changed the standard of care, said co-investigator Greg Durm, MD, of the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

“The particular analysis for this year was specifically looking at those patients on the trial who developed what we call immune-related adverse events,” Dr. Durm said. “These are things that come out as a result of the study drug enhancing their immune system.”

Investigators reported that despite receiving fewer cycles of consolidation pembrolizumab, patients who experienced any grade irAEs (excluding grade 1 pneumonitis) did not have significantly reduced efficacy outcomes.

“I took a couple things away from this,” Dr. Durm said. “We did not see an improvement in outcomes like we’ve seen in some of the stage IV trials. But if you’re treating your patients with consolidation immunotherapy, and they get a side effect that causes them to come off of treatment, I think you can feel a little bit better knowing that, at least in our trial, most people did not do any worse.”

Dr. Durm credits Indiana University School of Medicine fellow Nikhil A. Shukla, MD, for conducting the analysis.

See abstract.
 

GU14-188 Poster

The GU14-188 poster, titled “Phase Ib/II neoadjuvant (N-) pembrolizumab (P) and chemotherapy for locally advanced urothelial cancer (laUC): Final results from the cisplatin (C)- eligible cohort of HCRN GU14-188,” reported on the rate of pathologic muscle-invasive response in this cohort of subjects (cohort 1). Forty-three patients were accrued to cohort 1 of the study, which was designed to assess the tolerability and efficacy of neoadjuvant gemcitabine, cisplatin, and pembrolizumab in patients with locally advanced urothelial carcinoma.

Researchers concluded: Neoadjuvant chemo-immunotherapy with pembrolizumab in locally advanced UC has improved pathological outcomes compared to historic controls. Durable long-term survival in those with and without radical cystectomy is noteworthy in this advanced cohort.

GU14-188 is a multi-institution study led by Christopher Hoimes, DO, of Duke Cancer Institute.

See abstract.
 

GU14-188 Poster Discussion

The GU14-188 poster discussion, titled “Phase II neoadjuvant (N-) gemcitabine (G) and pembrolizumab (P) for locally advanced urothelial cancer (laUC): Interim results from the cisplatin (C)-ineligible cohort of GU14-188,” reported on subjects in cohort 2 of the non-randomized, two-arm study.

Researchers noted that patients with laUC who are cisplatin-ineligible have inferior survival compared to counterparts who receive cisplatin-based neoadjuvant therapy and have a pathologic response at radical cystectomy. Cohort 2 of the GU14-188 study is designed to assess the tolerability and efficacy of neoadjuvant gemcitabine and pembrolizumab in laUC patients who are cisplatin-ineligible.

Researchers concluded: Neoadjuvant gemcitabine with pembrolizumab in cisplatin-ineligible patients with laUC is feasible with manageable toxicity, and has a pathologic downstage rate comparable to standard of care in the cisplatin-eligible population. Gemcitabine and pembrolizumab warrants further study with component contribution as a cisplatin-free neoadjuvant option in laUC.

See abstract.
 

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 210 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 8,500 subjects have participated in Hoosier Cancer Research Network clinical trials.