Ghassan K. Abou-Alfa, MD, a medical oncologist, Memorial Sloan Kettering Cancer Center, discusses areas ripe for further exploration in hepatocellular carcinoma (HCC).

Efforts are underway to examine the immune microenvironment in patients with HCC, according to Abou-Alfa. Researchers at Memorial Sloan Kettering (MSK) Cancer Center are collecting tissue samples, along with demographic and treatment information, from patients with HCC around the world to better understand the molecular components of the immune microenvironment, Abou-Alfa says.

Advancements in cellular therapies for HCC and other solid tumors will be another area of interest in the coming years, Abou-Alfa adds.

Ensuring all patients with HCC have access to treatment remains a priority, Abou-Alfa says. The highest rates of liver cancer due to hepatitis C are found in Africa, particularly Egypt, according to Abou-Alfa. The highest incidence rates of liver cancer stemming from hepatitis B are also in Africa, Abou-Alfa adds. Bearing this in mind, in conjunction with colleagues in Africa, MSK researchers conducted a study to examine access to therapy across the continent for patients with liver cancer, Abou-Alfa concludes.

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Ghassan K. Abou-Alfa, MD, discusses areas ripe for further exploration in hepatocellular carcinoma.


Dr. Abou-Alfa on Areas Ripe for Further Exploration in HCC

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the efficacy of Ivosidenib (Tibsovo) in 

-mutant cholangiocarcinoma based on the results of the phase 3 ClarIDHy study (NCT02989857).

The results of the study were positive, based on a primary end point of progression-free survival (PFS), which demonstrated clear disease suppression at 6 months and 12 months, Abou-Alfa says. Notably, 70% patients from the placebo arm crossed over to receive ivosidenib with a clear improvement in survival.

Patients on the ivosidinib arm experienced a significant improvement in median overall survival (OS) of up to 10.3 months, while patients on the placebo arm who did not crossover had a rank-preserving structural failure time–adjusted OS of 5.1 months, Abou-Alfa says. This translated to a doubling of survival, which is not ordinarily observed in cholangiocarcinoma, he says.

Additionally, the adverse effects associated with the agent were limited and quality of life was also in favor of ivosidenib, Abou-Alfa explains. Having wide availability of ivosidenib for patients with cholangiocarcinoma would be an exciting prospect, Abou-Alfa concludes.

Ghassan K. Abou-Alfa, MD, discusses the efficacy of ivosidenib in IDH1-mutant cholangiocarcinoma based on the results of the phase 3 ClarIDHy study.

Dr. Abou-Alfa on Efficacy With Ivosidenib in IDH1+ Cholangiocarcinoma

Ghassan K. Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, discusses key eligibility criteria for the phase 3 PROOF trial (NCT03773302) in cholangiocarcinoma.

The PROOF study is evaluating oral infigratinib (BGJ398) as first-line treatment for patients with cholangiocarcinoma whose tumors harbor 

The study is ongoing and currently recruiting patients.

Eligible patients have to have a confirmed diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma with a confirmed 

 gene fusion or translocation, says Abou-Alfa. Additionally, patients have to have an available tissue sample for molecular testing, an ECOG performance status of 0 or 1, be able to swallow and retain oral medication, and a willingness to avoid pregnancy or fathering children.

Exclusion criteria include prior systemic therapies, a history of liver transplant, and prior FGFR or MEK inhibitor therapy, among other criteria that could influence outcomes, Abou-Alfa concludes.

Ghassan K. Abou-Alfa, MD, discusses key eligibility criteria for the phase 3 PROOF trial in cholangiocarcinoma.



Dr. Abou-Alfa on Key Eligibility Criteria for the PROOF Trial in Cholangiocarcinoma

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the plethora of new treatment options in advanced hepatocellular carcinoma (HCC).

2018 was a breakthrough year for the previously stagnant field of HCC. Since 2007, there had only been 1 FDA-approved drug, sorafenib (Nexavar), which was followed by negative trial after negative trial. This past year, however, several new drugs have received FDA approval. Most recently, the TKI lenvatinib (Lenvima) was granted approval for use in the frontline setting, after having demonstrated noninferiority to sorafenib for overall survival in patients with unresectable HCC.

In the second-line setting, regorafenib (Stivarga) received FDA approval for patients who progress on sorafenib. The checkpoint inhibitor nivolumab (Opdivo) has a conditional FDA approval for the second-line setting as well, Abou-Alfa notes. Researchers will know more about the role of immunotherapy in this space when results from the CheckMate-459 study are read out in the near future; this trial is evaluating nivolumab head-to-head with sorafenib in patients with advanced HCC.

Cabozantinib (Cabometyx) and ramucirumab (Cyramza) also have indications for the second-line of treatment, he adds.

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the plethora of new treatment options in hepatocellular carcinoma.

Ghassan Abou-Alfa, MD

Articles

Dr. Abou-Alfa on Areas Ripe for Further Exploration in HCC

Dr. Abou-Alfa on Efficacy With Ivosidenib in IDH1+ Cholangiocarcinoma

Dr. Abou-Alfa on Key Eligibility Criteria for the PROOF Trial in Cholangiocarcinoma

Dr. Abou-Alfa Discusses New Treatment Options in HCC