Ana Oaknin, MD, PhD, on Cervical Cancer: Safety and Efficacy Results With Nivolumab and Ipilimumab
ESMO Congress 2022
Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses findings from the CheckMate 358 trial, which showed that chemotherapy-free immunotherapy with nivolumab alone or in combination with ipilimumab may provide durable tumor regression with manageable toxicity in patients with recurrent or metastatic cervical cancer, regardless of tumor PD-L1 expression (Abstract 520MO).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
CheckMate 358 is an ongoing Phase I/II study analyzing the role of nivolumab and nivolumab/ipilimumab combination in virus-associated cancer, including cervical cancer, regardless of PDL1 status. In the cervical cancer cohort, recovering metastatic cervical cancer patients were randomized into two arms, nivolumab plus ipilimumab in two different regimens: NIVO 1 IPI 3, or NIVI 3 IPI 1. These combinations were analyzed in the first-line setting and the second-line. The primary objective of the study was overall response rate and secondary objective progression-free survival, overall survival, and duration of response. The two-treatment combination show promising overall response rate, and remarkably, we observe greater responses when the patient received this combination of first-line therapy. Interestingly, the combination show responses regardless of PDL1 status. And when we saw the response rate in this combination were greater that we saw with nivolumab monotherapy.
In addition, PFS and overall survival were really, really promising. When we look at the median overall survival for those patients treated with NIVO 1 IPI 3, was around 20 months and interestingly 48% of the patients were alive up to NGS. However, this data should be interpreted with caution because the trial is not fully randomized and the population was a mixed population. The safety profile of the combination in this study was aligned with the previous reported data. We need to say that some adverse events, such as hepatitis and colitis seem to be higher for those patients treated with nivolumab 1 ipilimumab 3. But in conclusion, I can say that outcome from the NIVO 3 combination show very, very promising outcome, and it may be considered as a kind of chemotherapy free regimen for our patient with metastatic recurrent cervical cancer.
Laurence Buisseret, MD, PhD, of Belgium’s Institut Jules Bordet, discusses phase II results from the SYNERGY trial, which tested first-line chemoimmunotherapy of durvalumab, paclitaxel, and carboplatin with or without the anti-CD73 antibody oleclumab in patients with advanced or metastatic triple-negative breast cancer. Although adding oleclumab to durvalumab with chemoimmunotherapy did not increase the clinical benefit rate at week 24, research is ongoing to better understand the mechanisms of response and resistance to this study combination (Abstract LBA17).
Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, and Laurence Albiges, MD, PhD, of France’s Gustave Roussy Cancer Centre, discuss phase III findings showing that cabozantinib in combination with nivolumab and ipilimumab reduced the risk of disease progression or death compared with the combination of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma of IMDC (the International Metastatic RCC Database Consortium) intermediate or poor risk. However, the combination of cabozantinib, nivolumab, and ipilimumab vs nivolumab plus ipilimumab did not demonstrate an overall survival benefit to patients (Abstract LBA8).
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses recent findings on the safety and antitumor activity of enfortumab vedotin-ejfv given intravenously as monotherapy or in combination with pembrolizumab to previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (Abstract LBA73).
Thomas Powles, MD, PhD, of Barts Health NHS Trust, Queen Mary University of London, and Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, discuss two important phase III studies on renal cell cancer (RCC) presented at ESMO 2022: IMmotion010, which examined the efficacy and safety of atezolizumab vs placebo as adjuvant therapy in patients with RCC at increased risk of recurrence after nephrectomy; and CheckMate 914, which compared nivolumab monotherapy or nivolumab combined with ipilimumab vs placebo in patients with localized disease who underwent radical or partial nephrectomy and who are at high risk of relapse. (Abstract LBA4 & LBA66).
John B.A.G. Haanen, MD, PhD, of The Netherlands Cancer Institute, discusses recent phase III findings, which show that tumor-infiltrating lymphocytes (TILs) improve progression-free survival compared with ipilimumab by 50% in patients with advanced melanoma after not responding to anti–PD-1 treatment. Around 50% of TIL-treated patients had a response, and 20% had a complete response (Abstract LBA3).