Immune Checkpoint Inhibitor Data Anticipated at ASCO

Immune checkpoint inhibition will continue to attract interest at the 2015 ASCO Annual Meeting, with a number of abstracts focused on this emerging class of agents. The checkpoint inhibitors nivolumab (Opdivo) and ipilimumab (Yervoy) are generating the most excitement in the immuno-oncology class. Additionally, emerging monoclonal antibodies targeted against PD-L1, PD-1, and CTLA-4 are also registering among the highlights.

While some data has been released, a majority of the most impactful news remains to be seen. More than 5000 abstracts will be presented at the conference, with only a few picked as late-breaking abstracts (LBAs). For these items, data will be released shortly before the presentation.

Researchers will report survival data from two phase III trials involving the PD-1—targeting immunotherapy agent nivolumab in non-small cell lung cancer (NSCLC) and another study in which the drug was combined with ipilimumab in melanoma. Nivolumab already is approved in both tumor types; the new data are expected to provide a more extensive picture of its efficacy in NSCLC and the potential to improve outcomes in melanoma by pairing the drug with the CTLA-4-targeting ipilimumab.

CheckMate-017 compared nivolumab with docetaxel as second-line therapy among 272 patients with squamous cell NSCLC (Abstract 8009), while CheckMate-057 evaluated the agent as second-line therapy in advanced nonsquamous NSCLC (Abstract LBA109). Positive results are anticipated from both trials, particularly CheckMate-057, which developer Bristol-Myers Squibb said was halted early after meeting its primary overall survival endpoint.

In the CheckMate-067 trial, initial efficacy and safety data will be presented for the combination of nivolumab plus ipilimumab as a first-line treatment for patients with advanced melanoma (Abstract LBA1). The phase III trial was launched after the combination achieved promising results in an earlier clinical trial.

In addition to the late-stage clinical trial findings, there are many studies that are expected to help physicians determine optimal uses for other established and emerging immune checkpoint inhibitors. Here are some of the agents that oncology thought leaders, analysts, and the companies themselves consider noteworthy:

• MEDI4736—Safety and efficacy data will be reported from a clinical trial in which the PD-1 inhibitor is paired with tremelimumab, which targets CTLA-4, in patients with NSCLC (Abstract 3014). AstraZeneca, which is developing the drug through its MedImmune research arm, has obtained a fast-track designation from the FDA for MEDI4736 as monotherapy for patients with advanced NSCLC.
• Pembrolizumab (Keytruda)—Findings about Merck’s PD-1 inhibitor will be reported across a broad range of tumor types in approximately a dozen abstracts, with notable results expected in advanced squamous cell carcinoma of the head and neck (LBA6008) and in the potential for the use of mismatch repair deficiency as a biomarker for response to the therapy in multiple tumor types (LBA100).
• Avelumab—Updates on early clinical trial data will be provided for this PD-L1 inhibitor in metastatic or locally advanced solid tumors, recurrent ovarian cancer, and NSCLC (Abstracts 3044, 5509, and 8034). Merck Serona and Pfizer are collaborating on the development of this agent.

ASCO abstracts are available athttp://abstracts.asco.org. For breaking news and updates during the meeting, visitwww.targetedonc.com.

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