|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Neoadjuvant immunotherapy and targeted therapy have been linked to high pathological complete response rates in patients with clinical stage III melanoma, according to data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Patients who achieved pathological complete response were subsequently more likely to be free of relapse at 12 months compared with those who did not achieve pathological complete response, the researchers found. Among those with pCR, no patient who received neoadjuvant immunotherapy has recurred.
For the study, researchers pooled data from 6 neoadjuvant systemic therapy trials of anti–PD-1 based immunotherapy or BRAF/MEK-targeted therapy conducted in institutions participating in the International Neoadjuvant Melanoma Consortium. The data included 184 patients with RECIST-measurable, surgically resectable clinical stage III melanoma who completed neoadjuvant systemic therapy and underwent surgery. Of all the patients, 133 completed neoadjuvant immunotherapy and 55 completed targeted therapy. The participants’ median age was 57 years. Median follow-up after surgery was 13 months. Neoadjuvant systemic therapy regimens included nivolumab — either as monotherapy or in combination with ipilimumab, pembrolizumab, or dabrafenib plus trametinib.
A pathological complete response (pCR) was found in 41% of patients including 51 (38%) patients who received immunotherapy and 24 (47%) who received targeted therapy. Of all 184 patients analyzed in the study, 44 (24%) have had disease that recurred — a group that included 18 (14%) who received immunotherapy and 26 (51%) who received targeted therapy. At 12 months, 83% of patients who received immunotherapy remained relapse-free compared with 65% of those who received targeted therapy (P <.001).
Among patients with pCR, 7% had their disease recur — a group that included no patients from the immunotherapy group and 7 out of 17 (41%) patients who received targeted therapy.
Among patients without pCR, 34% had their disease recur, including 18 out of 82 (22%) patients who received immunotherapy and 19 out of 27 (70%) patients who received targeted therapy.
Relapse-free survival at 12 months was improved in patients with pCR compared with those without pCR. Specifically, 95% of patients with pCR were free of relapse at 12 months compared with 62% of patients without pCR (P <.001). Among patients who received immunotherapy, all of those with pCR were free of relapse at 12 months compared with 72% of those without pCR (P <.001).
Among patients who received targeted therapy, 88% of those with pCR were free of relapse at 12 months compared with 43% of those without pCR (P <.001). The researchers also found that 16 (9%) patients have died, including 2 patients who had a pCR and received targeted therapy.
“In conclusion, neoadjuvant immunotherapy and targeted therapy are active regimens in resectable stage III melanoma; they’re associated with a high pathological complete response rate,” said lead study author Alexander M. Menzies, PhD, MBBS, FRACP, a medical oncologist and associate professor of melanoma medical oncology at Melanoma Institute Australia, Wollstonecraft. “The ability to achieve pCR correlates with improved recurrence-free survival. And I think this is a new benchmark for rapid drug development and regulatory approval.”
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Menzies AM, Rozeman EA, Amaria RN. Pathological response and survival with neoadjuvant therapy in melanoma: A pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC).Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 9503.