Dedicated Efforts Are Paying Off in Immunotherapy

OncLive Chairman,

Mike Hennessy

In recent years, immunotherapy advancements have generated much excitement in oncology, and that is no different in the urologic arena. We have been reporting on these developments as they come up, and so far, we have seen progress this year for understanding, developing, and gaining regulatory approval for immunotherapies in urologic cancers.

In our cover story for this issue, “More Therapies Targeting PD-1/PD-L1 Pathway in Bladder Cancer Emerge,” we review the latest information given on several of these treatments being developed for urothelial cancers, including atezolizumab (Tecentriq), pembrolizumab (Keytruda), nivolumab (Opdivo), avelumab (Bavencio), and durvalumab (Imfinzi).

Atezolizumab was granted accelerated approval by the FDA in May 2016 as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC). Although results from the IMvigor 210 study showed that patients treated with atezolizumab experienced clinically meaningful benefits, recently it was announced that the IMvigor 211 trial did not meet its primary endpoint of overall survival compared to chemotherapy for patients with metastatic UC.

Pembrolizumab has shown great promise when combined with chemotherapy in patients with previously treated metastatic UC, according to preliminary data from an ongoing trial led by Primo N. Lara Jr, MD, a urologic oncologist at the University of California, Davis. The data from this trial are described in detail in our conference coverage section of this issue.

Avelumab is also showing promising efficacy and safety in treating patients with metastatic UC. In an exciting development, avelumab was granted accelerated approval by the FDA in early May, 2017. Avelumab is now approved for patients with mUC who have disease progression following platinum-containing chemotherapy.

In February, the FDA granted an accelerated approval to nivolumab monotherapy as a treatment for patients with locally advanced unresectable or metastatic UC following progression on a platinumcontaining therapy. However, nivolumab is also doing well in recent combination therapy trials. In combination with ipilimumab (Yervoy), patients with metastatic UC saw a benefit after having no response to single-agent nivolumab. This tells us a great deal, and will help design more robust and effective combination therapies moving forward.

Durvalumab also has been demonstrating compelling clinical activity not only for patients with locally advanced or metastatic UC, but also in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) in prostate cancer. Durvalumab was recently granted accelerated approval by the FDA for patients with metastatic or locally advanced UC who have disease progression during or following platinum-containing chemotherapy. Could durvalumab be the “dark horse” in this race for developing immunotherapies for a wider net of urologic cancers?

We will certainly continue to report on durvalumab’s development moving forward, as well as all the other immunotherapies as they progress toward clinical utility.