Bristol-Myers Squibb’s (BMS’) Phase III study of Opdivo (nivolumab) in patients with hepatocellular cancer (HCC), the main type of liver cancer, who have not received prior treatment has experienced delays to the presentation of its results, according to a source familiar with the trial. The results were originally planned for release at the American Society of Clinical Oncology (ASCO) annual conference earlier this month in Chicago, the source said on the sidelines of the meeting, who noted there were not enough patient deaths needed to analyse the trial outcome.

The Phase III trial (NCT02576509), also known as CheckMate-459, randomises patients to two arms — receiving either Opdivo or comparator Bayer’s Nexavar (sorafenib). Analysts are expecting results of CheckMate-459 in 2H18 to early 2019. Sales across all indications are estimated to reach $9.4bn by 2022, with analysts noting growth potential upon first-line HCC expansion.

The company is now aiming to present the results at the European Society for Medical Oncology (ESMO) conference held 19-23 October in Germany, the source said. A shell abstract for a Phase III trial has been submitted for consideration by ESMO, the source said. However, BMS presenting data at the congress would be dependent on if there are enough death events in the trial a week before the late-breaking abstract deadline of 17 September, the source added.

If there are not enough deaths before the ESMO deadline, the abstract would then be submitted to the January 2019 ASCO Gastrointestinal Cancer Symposium, the source added.

BMS did not respond to a request for comment.

Second-line Opdivo impact on trial data

This lacking number of death events have been concerning, as there is the possibility that trial patients’ use of Opdivo for second-line therapy could be extending overall survival rates, which is the primary endpoint, the source said. According to the trial, if the patient progresses on both therapies, the trial allows for prescription of Opdivo as a second-line treatment. This means that there is the risk of Opdivo not delivering statistically significant improvement over the comparator, Nexavar, the source added.

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US patients randomised in the trial have easy access to Opdivo — being approved for second-line use — and significant crossover to Opdivo could impact the front-line analysis, said Dr Teresa Macarulla, attending physician, Gastrointestinal Tumors Service, University Hospital of Vall d’Hebron, Barcelona, Spain, and Dr Tim Greten, deputy chief, Thoracic and Gastrointestinal Malignancies Branch, National Cancer Institute, Bethesda, Maryland.

European patients would not have as easy access to Opdivo as a second-line treatment, Macarulla said. Patients in the EU are able to gain access by paying for Opdivo out of pocket, even if it is not approved in their respective countries, the source noted. As the ongoing trial is a global trial, Macarulla added, regional differences in crossover are unlikely to be factored in the analysis. According to ClnicalTrials.gov, the trial is recruiting in 143 sites and 21 countries across North America, Europe and Australasia, though the source did not comment on access to second-line Opdivo in countries outside the US and EU.

During the first two years of the trial, there were many death events, which noticeably slowed down now that the trial is in its final stages, the source said. The Phase III is following patients for approximately 33 months, ClinicalTrials.gov shows.

Once there is enough Phase III data, BMS would divide patients according to their second-line therapy — separating patients who have received second-line Opdivo or not — and this would be added to the FDA approval package, the source said. Greten added Opdivo is a well-established second-line option and any trial with risk of crossover should have its data finalised as soon as possible to avoid skewing of first-line results.

Regarding side effects in the Phase III trial, immune-related adverse events, sometimes severe, have been reported but nonetheless manageable, the source said. For example, there have been reports of type one diabetes and hypothyroidism but not significant, the source added.

Reynald Castaneda is a reporter for Pharmaceutical Technology 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.