Abstract 506P
Background
Immunotherapy is a promising treatment option for advanced NSCLC; however, its efficacy may be limited by accumulation of hyaluronan (HA). PEGPH20 degrades tumor-associated HA and increases the efficacy of chemo- and immuno-therapeutic agents in animal models. Here we report efficacy and safety results of PEGPH20 plus pembro in a cohort of pts with Stage IIIB/IV NSCLC in the 2-cohort, phase Ib dose escalation (DE) and expansion (DX) HALO 107-101 study (NCT02563548).
Methods
This analysis included pts with advanced NSCLC and ≥1 prior platinum-based chemotherapy (DE: 1.6 µg/kg and 2.2 µg/kg of PEGPH20, 2 pts per dose) and pts with HA-high NSCLC (HA staining ≥25% of tumor surface), previously untreated or treated with 1 prior platinum-based chemotherapy (DX: 17 pts). PEGPH20 was given on days 1, 8, and 15 and pembro (DE = 2 mg/kg; DX = 200 mg) on day 1 of 21day cycles. Pts received enteric-coated aspirin (81 mg daily) for thromboembolism prophylaxis. Primary endpoints included: DE: doselimiting toxicity, recommended phase 2 dose (RP2D); DX: objective response rate (ORR). Secondary endpoints included: ORR (DE only), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results
Mean pt age was 68 years; 76% of pts had an ECOG PS 1, and 52% were women. The RP2D dose of PEGPH20 was 2.2 μg/kg. A total of 17 of 21 enrolled pts had evaluable tumor responses: 4 had a partial response, 8 had stable disease, and 5 had progressive disease. ORR was 24% and DCR 71%. PFS rates at 6, 12, and 18 months were 25%, 0%, and 0%, respectively, and OS rates were 62%, 47%, and 31%, respectively. Any-grade treatment-emergent adverse events (TEAEs) were reported in all pts, the most common events being muscle spasms (71%), myalgia (43%), nausea (38%), fatigue (29%), and peripheral edema (29%). Grade ≥3 TEAEs were reported in 57% of pts; 38% of pts experienced ≥1 serious adverse event (AE). There was 1 (5%) treatment-emergent thromboembolic AE.
Conclusions
The combination of PEGPH20 with pembro has an acceptable safety profile that is consistent with results from other PEGPH20 clinical trials and demonstrates activity in pts with locally advanced or metastatic NSCLC.
Clinical trial identification
NCT02563548.
Editorial acknowledgement
Medical writing support provided by Miriam Cohen, PhD, of Paragon Medica, Knutsford, UK, supported by Halozyme Therapeutics Inc.
Legal entity responsible for the study
Halozyme Therapeutics Inc.
Funding
Halozyme Therapeutics Inc.
Disclosure
E. Bertino: Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy: Takeda. V. Lin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Halozyme Therapeutics Inc. V. Kuruvadi: Full / Part-time employment: Halozyme Therapeutics Inc. T. Heineman: Leadership role, Shareholder / Stockholder / Stock options: Halozyme Therapeutics Inc. All other authors have declared no conflicts of interest.
Resources from the same session
457P - The prevalence of vitamin D deficiency in Thai cancer patients, its dynamics and association with cancer survival
Presenter: Chavapon Ngokngarm
Session: Poster display session
Resources:
Abstract
458P - Mutation tracking in circulating tumour DNA predicts relapse in completely resected EGFR-mutated NSCLC
Presenter: Martin Filipits
Session: Poster display session
Resources:
Abstract
460P - Mendelian randomization study showed no causality between metformin use and lung cancer risk
Presenter: Jiayi Shen
Session: Poster display session
Resources:
Abstract
461P - Blood trace minerals and lung cancer: A Mendelian randomization study
Presenter: Wei Xian
Session: Poster display session
Resources:
Abstract
463P - Prediction of invasiveness in lung adenocarcinoma using machine learning algorithm based on 3D-CT imaging
Presenter: Yusuke Saeki
Session: Poster display session
Resources:
Abstract
459P - Fish intake, dietary polyunsaturated fatty acids, and lung cancer: systematic review and dose-response meta-analysis of 1.7 million men and women
Presenter: Chao Cao
Session: Poster display session
Resources:
Abstract
462P - Usefulness for prevention of postoperative cerebrovascular complications in patients with lung cancer using carotid ultrasonography
Presenter: Sadanori Takeo
Session: Poster display session
Resources:
Abstract
468P - Histological type analysis of 10-year follow-up of WJTOG0105: A phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer
Presenter: Masahiro Tsuboi
Session: Poster display session
Resources:
Abstract
469P - Comparison of combined chemoradiotherapy regimens; Paclitaxel plus carboplatin and cisplatin plus etoposide for locally advanced non-small cell lung cancer: A randomised phase III trial
Presenter: Alper Ata
Session: Poster display session
Resources:
Abstract
472P - Integration of expression rate and absolute cell counts of PD-1+ stromal tumour-infiltrating lymphocytes: Prognostic significance in esophageal squamous cell carcinoma
Presenter: Qingkun Song
Session: Poster display session
Resources:
Abstract