A phase Ib study of pembrolizumab plus chemotherapy in patients with advanced cancer (PembroPlus) - PubMed (original) (raw)

Clinical Trial

. 2017 Jun 27;117(1):33-40.

doi: 10.1038/bjc.2017.145. Epub 2017 Jun 6.

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Clinical Trial

A phase Ib study of pembrolizumab plus chemotherapy in patients with advanced cancer (PembroPlus)

Glen J Weiss et al. Br J Cancer. 2017.

Abstract

Background: Pembrolizumab (P) is an anti-PD-1 antibody that blocks the interaction between programmed cell death protein 1 (PD-1) on T-cells and PD-L1 and PD-L2 on tumour cells. A phase Ib trial of P plus chemotherapy was undertaken to evaluate the safety and efficacy.

Methods: Patients with advanced, metastatic solid tumours were enrolled onto one of six treatment arms. Pembrolizumab was given: with gemcitabine (G), G+docetaxel (D), G+nab-paclitaxel (NP), G+vinorelbine (V) or irinotecan (I) until progression or toxicity, or with liposomal doxorubicin (LD) for up to 15 cycles, progression or toxicity. Safety monitoring and response assessments were conducted.

Results: Forty-nine patients were enrolled and treated. The most common adverse events were transaminitis, cytopenias, rash, diarrhoea, fatigue, nausea and vomiting. Arm 2 was closed due to poor accrual. The recommended phase II dose (RP2D) was determined for Arms 1, 3a, 4, 5 and 6. There were eight partial responses across multiple tumour types.

Conclusions: Standard dose P can be safely combined with G, G+NP, G+V, I and LD. Efficacy was observed in multiple tumour types and evaluation to determine if response and duration of response are more robust than what would be expected for chemotherapy or immunotherapy alone requires further validation.

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Conflict of interest statement

GJW: Consultant for Blend Therapeutics, Pharmatech, Viomics and Paradigm; Speakers' Bureau: Medscape, Merck, Novartis; Travel/accommodations: NantWorks. JN: Consultant for Astrazeneca and Eisai; JHF: Genentech speaker’s bureau; and VK: Consultant for Axcess Oncology. The remaining authors declare no conflict of interest.

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