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Durvalumab-tremelimumab combination shows antitumor activity in urothelial cancer
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The combination of durvalumab and tremelimumab demonstrated antitumor activity among patients with urothelial cancer, according to study results presented at American Association for Cancer Research Annual Meeting.
The combination also appeared well tolerated.
“Immunotherapy is active in metastatic urothelial cancer. Durvalumab [Imfinzi, AstraZeneca], a PD-L1 antibody, demonstrated promising safety and activity as part of a phase1/phase 2 trial, which led to the accelerated approval in the postplatinum setting,” Arjun V. Balar, MD, director of the genitourinary medical oncology program at NYU Langone’s Perlmutter Cancer Center, said during his presentation. “The anti-CTLA-4 antibody tremelimumab [MedImmune] may provide additional antitumor synergistic activity through augmented T-cell responses and could augment activity when used in combination with durvalumab.”
Balar and colleagues assessed durvalumab plus tremelimumab in a study of 168 patients with platinum-refractory metastatic urothelial cancer.
Patients received 20 mg/kg durvalumab plus 1mg/kg tremelimumab every 4 weeks for four cycles, followed by 10 mg/kg durvalumab every 2 weeks for up to 12 months.
Eighty-one percent of patients had visceral metastases, including 32.1% with liver metastases, and 32.1% had received more than one prior line of chemotherapy.
At median follow-up of 11.6 months, researchers calculated an objective response rate of 20.8% (95%, 15-27.8), including four complete responses.
The 6-month PFS was 25.4% and the 6-month OS rate was 60.9%. Median PFS was 1.9 months and median OS was 9.5 months. However, the PFS and OS data “are relatively immature,” Balar said.
Researchers observed responses regardless of PD-L1 expression. However, patients with either tumor or immune cell expression of at least 25% appeared more likely to achieve response (29.4% vs. 15.1%) and achieve 6-month OS (66.4% vs. 51.9%) than those with less than 25% expression.
Median time to response was 1.8 months (95% CI, 1.8-1.8).
The majority (75.6%) of patients experienced treatment-related adverse events, and 28.6% experienced grade 3 or grade 4 events. One patients died due to pulmonary hemorrhage. Treatment-related adverse events led to discontinuation of therapy among 11.9% of patients. – by Cassie Homer
References:
Balar AV, et al. Abstract CT112. Presented at American Association for Cancer Research Annual Meeting; April 14-18, 2018; Chicago.
Disclosures: Balar reports research support from AstraZeneca, Genentech/Roche, Merck and Seattle Genetics, as well as consultant/advisory roles with AstraZeneca, EMD Serono, Genentech/Roche, Merck, Pfizer and Seattle Genetics. Please see the abstract for all other authors’ relevant financial disclosures.