Bayer’s 57-patient Phase Ib trial investigating Stivarga (regorafenib) plus Merck’s Keytruda (pembrolizumab) in first-line (1L) hepatocellular carcinoma (HCC) will have efficacy/safety data from the first 30 patients presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) in January, a source familiar with the trial said.

Confirmation of abstract approval was made in the past few days, the source added.

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Abstracts for ASCO-GI are scheduled for release mid-December, with the symposium to take place on 23–25 January 2020 in San Francisco, California. A Bayer spokesperson said Phase Ib data will be presented at a future medical meeting. Bayer cannot comment on any potential upcoming ASGO-GI presentations as abstract titles have yet to be published, she added.

Stivarga made $372m in 2018, with Keytruda having sales of $7.1bn. Stivarga is estimated to have $537m in sales in 2025, while Keytruda sales are predicted at $22.1bn in the same year, as per GlobalData consensus forecasts.

Bayer has a $ 71.5bn market cap.

ClinicalTrials.gov shows the open-label Phase Ib trial (NCT03347292) had a study start date of June 2018, with an estimated primary completion date of October 2020. Its primary endpoints are focusing on treatment-emergent adverse events and dose-limiting toxicities, with a follow-up period of 30 days after the last dose and 42 days after the first treatment administration, respectively. The trial has multiple secondary efficacy endpoints like progression-free survival and overall survival with a 36-month time frame.

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Phase Ib is divided into two parts. In the dose-escalation part of the trial, patients receive 80mg, 120mg or 160mg oral Stivarga once-daily three weeks on and one week off in combination with 200mg intravenous Keytruda.

This is followed by a dose-expansion portion where cohorts will continue to expand until the sample size of 30–35 patients per cohort is reached, ClinicalTrials.gov states.

Stivarga is approved for second-line HCC, colorectal cancer and gastrointestinal stromal tumours. Keytruda is used in a variety of cancers including second-line HCC, gastric cancer, oesophageal cancer, among others.

Multikinase inhibitor Stivarga is derived from Bayer’s Nexavar (sorafenib), which is the current 1L HCC standard-of-care. Nexavar made $840m in 2018, but sales are expected to drop to $64m by 2025, as per GlobalData consensus forecasts. Keytruda is an anti-PD1 monoclonal antibody therapy.

by Reynald Castaneda in London
Reynald Castaneda is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.