Richard Finn, MD, associate professor of Medicine at the UCLA David Geffen School of Medicine, discusses results of the RESOURCE study in advanced liver cancer.

In the past decade, sorafenib (Nexavar) has been the only active systematic agent in the treatment of patients with advanced liver cancer. Efforts to improve sorafenib thus far have failed in trials of both frontline and second-line settings.

RESOURCE, a large phase III, double-blind, placebo controlled randomized study, evaluated regorafenib (Stivarga) in patients with advanced liver cancer after progression on sorafenib. The primary endpoint for this study was overall survival (OS), with median progression-free survival, median time to disease progression and disease-control rates as secondary endpoints.

Regorafenib demonstrated an improvement in median OS, 10.6 months, as compared with the placebo arm at 7.8 months. All secondary endpoints were met as well.

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Dr. Finn on Results of RESOURCE Study in Liver Cancer

Richard Finn, MD, associate professor of Medicine at the UCLA David Geffen School of Medicine, discusses studies of pembrolizumab (Keytruda) in patients with previously untreated hepatocellular carcinoma (HCC).

Pembrolizumab, a PD-1 antibody, has moved into the second-line setting in HCC, states Finn. There are 2 ongoing studies, the first being a single-arm phase II study of pembrolizumab intravenously every 3 weeks for patients who had progressed or were intolerant of sorafenib (Nexavar). This is a global study that is aimed at collecting single-agent efficacy and safety data.

The second ongoing trial is a randomized global phase III study, which is focused on pembrolizumab versus placebo in a 2:1 randomization for patients who progressed or were intolerant of sorafenib. This is aimed to prove that anti PD-1 therapy in advanced liver cancer in the second-line setting will improve survival.

Dr. Finn on Studies of Pembrolizumab for Hepatocellular Carcinoma

Richard Finn, MD, associate professor of medicine at the UCLA David Geffen School of Medicine, discusses the promise of regorafenib (Stivarga) for the treatment of hepatocellular carcinoma (HCC), as seen in the phase III RESORCE trial. 

For the first time, a study has shown an improvement in median overall survival, from 7.8 months in the control arm to 10.6 months in patients who received sorafenib (Nexavar) followed by regorafenib. This represents a 37% decrease in the risk of death, Finn says.

Regorafenib is still awaiting full regulatory approval for this indication, but based on the data seen thus far, this should become the new standard of treatment for patients progressing on sorafenib, Finn says.

Dr. Finn on the Promise of Regorafenib for the Treatment of HCC

Richard Finn, MD associate professor of Medicine at the UCLA David Geffen School of Medicine, discusses what’s next for palbociclib following the PALOMA trials.

The FDA granted an accelerated approval to palbociclib as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer, based on findings from the phase II PALOMA-1 trial.

PALOMA-2 was a randomized double-blind phase III trial designed to confirm the results of PALOMA-1. The study found that adding the CDK 4/6 inhibitor to letrozole reduced the risk of disease progression by 42% compared with letrozole alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer.  

Based on the positives findings from both of these trials, palbociclib is being considered in the adjuvant setting, says Finn. There are studies looking at the combination of palbociclib and endocrine therapy in early-stage breast cancer.

What important question that should be addressed is if chemotherapy is still necessary in early stage-breast cancer, or the combination palbociclib and endocrine therapy would be enough, says Finn. The combination is very active, perhaps even more active than chemotherapy, he says.

A good adjuvant study would look at CDK 4/6 inhibitor plus endocrine therapy in patients who were high-risk for recurrence versus standard treatment, which include chemotherapy.

There are more conservation adjuvant studies ongoing, which hopefully will answer that question, says Finn. 

Richard Finn, MD associate professor of Medicine at the UCLA David Geffen School of Medicine, discusses what’s next for palbociclib following the PALOMA trials.
 

Richard Finn, MD

Articles

Dr. Finn on Results of RESOURCE Study in Liver Cancer

Dr. Finn on Studies of Pembrolizumab for Hepatocellular Carcinoma

Dr. Finn on the Promise of Regorafenib for the Treatment of HCC

Dr. Richard Finn on What's Next for Palbociclib After PALOMA in Breast Cancer