Hans Hammers, MD, PhD, is a professor in the Department of Internal Medicine, a member of the Division of Hematology and Oncology, coleader of Clinical Research and Immunotherapy for the Kidney Cancer Research Program, and the Eugene P. Frenkel, MD Scholar in Clinical Medicine at the University of Texas Southwestern Medical Center

Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the long-term benefits of the CheckMate-214 study in patients with renal cell carcinoma (RCC).

The CheckMate-214 study demonstrated that frontline treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) reduced the risk of death by 32% compared with sunitinib (Sutent) for patients with metastatic RCC. Across the full study, the confirmed objective response rate was 39% and 32% (

 = .0191) in the nivolumab/ipilimumab group and sunitinib group, respectively.

Patients who are still on therapy and not progressing are in the single-digit range, explains Hammers. There is a 21% confirmed response rate from this study.

The phase I CheckMate-016 study investigating PD-1 and CTLA-4 demonstrates a plateau forming in progression-free survival of around 12% to 18%. According to Hammers, the combination of PD-1 and CTLA-4 inhibitors may provide a long-term benefit that is superior to PD-1 monotherapy.

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Dr. Hammers on the Long-Term Benefits of the CheckMate-214 Study in RCC

Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the CheckMate-214 study for patients with renal cell carcinoma (RCC).

CheckMate-214 is a large phase III trial that randomized 1000 patients to nivolumab (Opdivo) plus ipilimumab (Yervoy) or sunitinib (Sutent). The primary analysis was focused on the intermediate- and poor-risk patients, explains Hammers.

A median progression-free survival (PFS) was a challenge to achieve, but according to Hammers, the combination will become the new standard of care.

Dr. Hammers on the CheckMate-214 Study for RCC

Hans J. Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the potential combination of IDO inhibitors and PD-1 inhibitors in renal cell carcinoma (RCC).

Interfering in the IDO pathway can result in a tumor microenvironment that allows for a more enhanced immune response, says Hammers.

Early data out of ASCO 2017 showed an improved response rate with the combination of an IDO inhibitor and a PD-1 inhibitor, resulting in a phase III trial comparing that combination to sunitinib (Sutent) in RCC.

Hans J. Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the potential combination of IDO inhibitors and PD-1 inhibitors in renal cell carcinoma.
 

Dr. Hammers Discusses Combining IDO and PD-1 Inhibitors in RCC

Hans J. Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the combination of vaccines and immune checkpoint inhibitors in the treatment of patients with renal cell carcinoma (RCC).

It is time to revisit vaccines, Hammers says, particularly in combinations. Approaches to this include allogenic vaccines for easy, over-the-counter use, and tailor-made vaccines to fit the needs of a specific patient.

Hans J. Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the combination of vaccines and immune checkpoint inhibitors in the treatment of patients with renal cell carcinoma.

Dr. Hammers on Combination of Vaccines and Immune Checkpoint Inhibitors in RCC

Hans J. Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses immunotherapy in renal cell carcinoma (RCC).

In November 2015, nivolumab (Opdivo) was approved by the FDA for the second-line treatment of patients with RCC. Response rates are around 20% with moderate activity, says Hammers, but this can be improved with combinations.

Nivolumab in combination with targeted agents such as VEGF inhibitors, or selective agents such as axitinib (Inlyta), could be promising, says Hammers. Durability and quality of response should be evaluated closely, though, to determine the synergy of the given agents.

PD-1 inhibitors and CTLA-4 inhibitors are also being looked at in combination in the phase III CheckMate-214 trial.

Dr. Hammers Discusses Immunotherapy in RCC

Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses HyperAcute Renal (HAR) immunotherapy in patients with renal cell carcinoma (RCC).

In a phase I study of alpha-1, 3-galactosyltransferase-expressing allogeneic RCC immunotherapy, patients with metastatic RCC were given injections of HAR for 4 weeks (150 x106 cells/300 x106 cells intradermally). This was followed by 10 weeks of bi-weekly injections.

HAR was well tolerated in this population, says Hammers, and RCC was deemed an appropriate tumor type to target with combination immunotherapy.

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Dr. Hammers on Study of HyperAcute Renal Immunotherapy in RCC

Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses a mature data set regarding nivolumab (Opdivo) and ipilimumab (Yervoy) in the treatment of patients with renal cell carcinoma (RCC).

Hammers discusses a trial which randomized patients to receive either high-dose ipilimumab plus nivolumab or low-dose ipilimumab in combination with nivolumab.

The results showed robust antitumor activity with a response rate of 40%. The progression-free survival was close to what oncologists typically would like to see with tyrosine kinase inhibitors, at 6 to 9 months. Both the duration and rapidity of response, says Hammers, is quite encouraging for immunotherapy and indicates that it is a very active regimen.

In terms of the safety profile findings, low-dose ipilimumab was found to be better tolerated for patients with RCC, with roughly 30% of patients experiencing grade 3 or 4 toxicities.

Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses a mature data set regarding nivolumab and ipilimumab in the treatment of patients with renal cell carcinoma.

Hans Hammers, MD, PhD

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