|The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Combination immunotherapy with nivolumab and ipilimumab provided intracranial and extracranial responses for patients with melanoma and brain metastases, according to data from CheckMate 204 (ClinicalTrials.gov Identifier: NCT02320058) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
CheckMate 204, presented by Hussein Tawbi, MD, of the MD Anderson Cancer Center in Houston, Texas, was a phase 2 study, which enrolled patients with melanoma and asymptomatic brain metastases (0.5 – 3.0 cm) who were not receiving steroids.
Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks for 4 cycles and then nivolumab 3 mg/kg every 2 weeks until disease progression or toxicity. Patients with severe adverse reactions on the combination were allowed to receive nivolumab monotherapy once toxicity resolved.
The primary endpoint was intracranial clinical benefit rate (complete response [CR], partial response [PR], or stable disease for longer than 6 months). Of the 154 patients accrued to the study, 109 received treatment, and data were presented for 75 patients who were assessed before data lock.
Of 49 patients who came off treatment, 23 were for drug toxicities, 16 for progressive disease, and 3 for maximum clinical benefit.
Median age was 59 years; median number of induction (combination therapy) doses was 3, with 35% of patients receiving all 4 combination doses and 51% receiving nivolumab maintenance.
After a median follow up of 6.3 months, intracranial objective response rate was 54%, with 21% of patients showing CRs and 33% showing PRs. Intracranial clinical benefit rate was 60%.
Six-month progression-free survival was 67% and was similar for patients showing intracranial and extracranial responses.
Grade 3 to 4 treatment-related adverse events occurred in 52% of patients, with 8% showing neurologic events. Treatment was discontinued by 4 patients (3 patients) for neurologic events.
One patient died of immune-related myocarditis.
The report suggests that the combination may change practice so that whole brain radiation or stereotactic radiation may be avoided or delayed.
“In patients with advanced melanoma and untreated brain metastases, the combination of nivolumab and ipilimumab demonstrates clinically meaningful efficacy, and can become a new treatment option,” Dr Tawbi concluded.
Read more of Cancer Therapy Advisor‘s coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Tawbi HA, Forsyth PA, Algazi AP, et al. Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: results of the phase II study CheckMate 204. J Clin Oncol. 2017;34(suppl; abstr 9507).