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
143P - NOTCH3 expression predicts poor survival in advanced esophageal squamous cell cancers
Presenter: Raja Pramanik
Session: Poster display session
Resources:
Abstract
144P - Severe hypovitaminosis D in metastatic gastric cancer patients from the Northern and Southern hemispheres: Data from the EXPAND phase III trial
Presenter: Radka Obermannova
Session: Poster display session
Resources:
Abstract
145P - Role of Glasgow prognostic score in chemo-naïve patients with advanced biliary tract cancer and good performance status
Presenter: Toshikazu Moriwaki
Session: Poster display session
Resources:
Abstract
146P - Anatomic versus non-anatomic resection for hepatocellular carcinoma: A meta-analysis of high-quality studies
Presenter: Bin Zhang
Session: Poster display session
Resources:
Abstract
147P - Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis
Presenter: Yingtai Chen
Session: Poster display session
Resources:
Abstract
148P - Efficacy of capecitabine and oxaliplatin versus S-1 as adjuvant chemotherapy in gastric cancer after D2 lymph node dissection according to lymph node ratio and N stage
Presenter: Seunghwan Lee
Session: Poster display session
Resources:
Abstract
150P - A Phase Ib Study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction
Presenter: Yee Chao
Session: Poster display session
Resources:
Abstract
151P - Gene expression profiling for a better understanding of gastric cancer: From the perspective of metabolic rearrangement
Presenter: Midie Xu
Session: Poster display session
Resources:
Abstract
152P - Long-term outcomes of three-dimensional conformal radiotherapy-based and intensity-modulated radiotherapy-based concurrent chemoradiotherapy in patients with thoracic esophageal squamous cell carcinoma
Presenter: Chia-Lun Chang
Session: Poster display session
Resources:
Abstract
153P - Exosomal LINC00174 facilitates epithelial-mesenchymal transition in residual hepatocellular carcinoma after insufficient radiofrequency ablation by regulating c-JUN/MYCBP/c-Myc axis
Presenter: Dening Ma
Session: Poster display session
Resources:
Abstract