The following article features coverage from the 2020 San Antonio Breast Cancer Symposium. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Lenvatinib plus pembrolizumab showed promising activity in patients with previously treated advanced triple-negative breast cancer (TNBC), according to data from the TNBC cohort of LEAP-005 presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS).

“Early phase 3 trials have shown promising clinical outcomes with the combination of lenvatinib plus pembrolizumab across several cancers,” explained Hyun C. Chung of Yonsei Cancer Center.

The phase 2 multicohort LEAP-005 study enrolled 31 patients 18 years or older with previously treated advanced TNBC. Patients were treated with lenvatinib 20 mg once daily plus pembrolizumab 200 mg every 3 weeks for a maximum of 35 pembrolizumab doses followed by lenvatinib alone until progressive disease or unacceptable toxicity.

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More than half (58%) of patients had 2 or more prior lines of therapy; 26% had a combined positive score of 10 or more tumors.

With a median follow-up of 7 months, 78% of patients had a decrease from baseline in the size of target lesions. The objective response rate was 29% with one complete response and eight partial responses. The disease control rate was 58%.

The 1 complete response and 3 partial responses were in patients with CPS of 10 tumor or more, for an ORR of 50%. Five of the partial responses were in patients with a CPS of less than 10 tumors for an ORR was 23%. Responses were durable with the median duration of response was not reached; 78% of responses are ongoing at data cutoff.

The median progression-free survival was 4.2 months and the estimated progression-free survival at 6 months was 49%.

More than half (55%) or patients had treatment-related adverse events of grade 3 to 5. Ten percent of patients discontinued due to treatment-related adverse events.

Read more of Cancer Therapy Advisor‘s coverage of the 2020 SABCS meeting by visiting the conference page.


Chung HC, et al. Lenvatinib plus pembrolizumab for previously treated, advanced triple-negative breast cancer: early results from the multicohort phase 2 LEAP-005 study. Presented at: 2020 Virtual San Antonio Breast Cancer Symposium (SABCS); December 8-11, 2020. Abstract PS12-07.