In the phase 2 component of the phase 2/3 BEER-BTC study, bevacizumab plus erlotinib improved outcomes in patients with advanced biliary tract cancers.
Gemcitabine/cisplatin plus durvalumab or pembrolizumab are first-line treatment options for patients with advanced biliary tract cancer (BTC); however, evidence is limited for maintenance therapy in these patients. Individually and in combination, bevacizumab and erlotinib have shown efficacy in patients with BTC. At the 2023 ESMO Conference in Madrid, Spain, Anant Ramaswamy, MD, presented the results of the phase 2 component of the BEER-BTC study, which evaluated the efficacy of bevacizumab and erlotinib maintenance therapy after gemcitabine-based chemotherapy in patients with advanced cholangiocarcinoma (CCA).
Anant Ramaswamy, MD, presented the results of the phase 2 component of the BEER-BTC study, which evaluated the efficacy of bevacizumab and erlotinib maintenance therapy after gemcitabine-based chemotherapy in patients with advanced cholangiocarcinoma (CCA).
This study is an integrated phase 2/3 randomized clinical trial (Clinical Trial Registry of India: CTRI/2020/03/023943) conducted at 2 centers in India. Eligible patients were aged 18 to 75 years with advanced BTC who had responsive or stable disease status following 6 months of gemcitabine-based chemotherapy and were randomly assigned (1:1) to either the observation arm or the intervention arm (BEER). The intervention arm was a combination of bevacizumab 5 mg/m2 intravenously every 21 days plus erlotinib 100 mg once daily. The primary end point of the phase 2 component of this trial was progression-free survival (PFS) measured from enrollment into the trial. Secondary end points consisted of overall survival (OS), adverse events, serious adverse events, and proportion of treatment completion.
A total of 90 patients (observation, 45; BEER, 45), comprised of 78 patients with gallbladder cancer and 20 patients with CCA, were randomized. With a median follow-up of 13.4 months, patients in the BEER cohort showed an improved PFS versus the observation cohort (5.3 months vs 3.1 months; P=.001). No grade 4 adverse events were reported, but grade 3 events consisted of decreased platelet count, acneiform rash, oral mucositis, fatigue, abdominal pain, and epistaxis (all in 1 [2%] patient) in the observation arm, and in the BEER arm, 1 adverse event of vomiting was reported (1 [2%] patient).
In this phase 2 clinical trial, bevacizumab plus erlotinib improved PFS in patients with chemotherapy-responsive advanced BTC. The ongoing phase 3 component of this study will evaluate whether the significant benefit in PFS translates to improvement in OS.
Source:
Ostwal V, Ramaswamy A, Bhargava P, et al. Bevacizu-mab plus erlotinib as switch maintenance in chemotherapy responsive in advanced biliary tract cancers (BEER-BTC): a multicentre, open-label, randomized, controlled, phase 2 trial. Presented at: ESMO Congress 2023, October 20-24, 2023; Madrid, Spain.