Patrick Daly

DocwireNews

In ESMO Open, Enrique Grande, MD, and collaborating researchers published findings from the IMMUNOSUN trial on the safety and efficacy of sunitinib as a pure second-line treatment for patients with metastatic <a href="https://www.cancer.gov/types/kidney/patient/kidney-treatment-pdq#:~:text=Renal%20cell%20cancer%20(also%20called,filter%20and%20clean%20the%20blood.">renal cell carcinoma</a> (mRCC). They felt that, despite the IMMUNOSUN trial not reaching the prespecified endpoint, &ldquo;it demonstrated that sunitinib is active and can be safely used as a second-line option in patients with mRCC who progress to new standard ICI-based regimens.&rdquo;The authors had designed the phase 2 trial to help inform second-line treatment selection guidelines for patients who progressed to ICI-based treatments. They noted that IMMUNOSUN is one of few trials to have evaluated a single tyrosine kinase inhibitor (TKI) after ICI-based therapy failure in mRCC.The phase 2 single-arm trial was conducted at 10 centers within the Spanish Oncology Genitourinary Group (SOGUG). Participants had a confirmed diagnosis of mRCC with a clear-cell component who had progressed to first-line immune checkpoint inhibitor (ICI)-based regimens. All patients received once-daily oral sunitinib 50 mg for 4 weeks, followed by a 2-week rest period, as per package instructions. The primary endpoint of the trial was the objective response rate.<h3>Second-Line Metastatic Renal Cell Carcinoma Treatment Data</h3>A total of 21 patients were included in the final analyses. Reportedly, all patients showed partial responses, 4 (19.0%) patients achieved objective responses (95% CI, 2.3%-35.8%), and 14 (67%) patients had a stable response, leading the authors to report a clinical benefit for 18 (85.7%) patients (95% CI, 70.7%-100%). Among the 4 objective response patients, the median response duration was 7.1 months (IQR: 4.2-12.0), median progression-free survival (PFS) was 5.6 months (95% CI, 3.1-8.0), and median overall survival was 23.5 months (95% CI, 6.3-40.7). Additionally, the investigators observed that patients with better antitumor responses to first-line ICI-based therapies exhibited longer PFS and OS with sunitinib treatment.Regarding safety, the most frequent treatment-emergent adverse events were diarrhea (52%), dysgeusia (38%), palmar-plantar erythrodysesthesia (38%), and hypertension (38%). One patient experienced grade 5 pancytopenia, 11 patients experienced grade 3 adverse events, 8 patients had serious adverse events, of which four were judged to be treatment-related.The article noted that the study was limited by its uncontrolled design, a heterogenous distribution of first-line treatments, the small sample size, and lack of patients with prior ICI+TKI-based treatments.Regardless, the authors considered the efficacy &ldquo;remarkable,&rdquo; though they reported that median PFS appeared shorter than with alternatives in the same setting. Overall, the authors concluded that sunitinib seems to mirror the efficacy of first-line treatment, and that safety signals were consistent with experience during first-line treatment.View More <a href="https://www.docwirenews.com/prostate-cancer-resource-center/">Recent Research and Expert Discussions</a> on Oncology and Hematology.

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In ESMO Open, Enrique Grande, MD, and collaborating researchers published findings from the IMMUNOSUN trial on the safety and efficacy of sunitinib as a pure second-line ...

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