Long-Term Follow Up of CheckMate 205 Confirms Nivolumab Efficacy in Relapsed/Refractory Hodgkin Lymphoma

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Similar ORR was reported for patients regardless of prior exposure to brentuximab vedotin (BV).
Similar ORR was reported for patients regardless of prior exposure to brentuximab vedotin (BV).

In a long-term follow-up of CheckMate 205, nivolumab therapy provided objective response rate (ORR) of 69% for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) after failure of autologous hematopoietic cell transplantation (auto-HCT).1

Similar ORR was reported for patients regardless of prior exposure to brentuximab vedotin (BV), which is currently approved treatment for cHL in the front-line (with chemotherapy) as well as the relapsed/refractory setting.2

“[T]his is the longest phase 2 or 3 follow-up reported to date of anti-PD-1 [program death-1] checkpoint blockade in patients with a hematologic malignancy,” the CheckMate 205 study authors concluded.

CheckMate 205 was a phase 2 single-arm study that enrolled three cohorts of patients: patients with no prior BV exposure (cohort A: 63 patients); patients who failed post-auto-HST BV treatment (cohort B: 80 patients); and patients who were treated with BV before or after auto-HST (cohort C: 100 patients).

The primary endpoint was independent radiology review committee (IRC)-assessed ORR in each cohort according to the 2007 International Working Group (IWG) criteria.

At datalock of December 2016, median follow-up was 18 months — 19, 23, and 16 months for cohorts A, B, and C, respectively. Forty percent of patients continued to receive nivolumab and patients in cohorts A, B, and C received a median of 32, 32, and 27 doses, respectively.

For the 69% of patients with an ORR, 16% achieved a complete response (CR) and 53% achieved a partial response (PR). ORR for patients in cohorts A, B, and C were 65%, 68%, and 73%, respectively. CR across cohorts A, B, and C were 29%, 13%, and 12%, respectively; correspondingly, partial responses were 37%, 55%, and 61%, respectively.

Median time to first response was 2.1 months for the entire cohort of patients and median duration of response (DOR) was 16.6 months. Median DOR was highest for cohort A: 20.3 months compared with 15.9 months for cohort B and 14.5 months for cohort C.

Median progression-free survival (PFS) was 14.7 months the entire cohort and 18.3, 14.7, and 11.9 months for patients in cohorts A, B, and C, respectively.

Median PFS was also analyzed based on best response. Patients with CR had a median PFS of 22.2 months compared with 15.1 and 11.2 months for those with PR and stable disease, respectively.

Time to next treatment (TTNT), defined as the time from the first nivolumab dose (or from initial disease progression in case of TBP) to next systemic therapy, was also notable for patients. Median TTNT was 19.4 months for patients in cohort C, and was not reached in the other two cohorts.

Median overall survival (OS) was not reached for any cohort of patients as well as for patients based on their best response.

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