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Attend this session at the
2019 ASCO Annual Meeting!


Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Sunday June 2, 8:00 AM to 11:00 AM

Location: Hall A

Project Switch: Docetaxel as a potential synthetic control in metastatic non-small cell lung cancer (mNSCLC) trials.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
9105

Poster Board Number:
Poster Session (Board #428)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 9105)

Author(s): Michael E. Menefee, Yutao Gong, Pallavi Shruti Mishra-Kalyani, Rajeshwari Sridhara, Bindu Kanapuru, Gideon Michael Blumenthal, Richard Pazdur; FDA, Silver Spring, MD; U.S. Food and Drug Administration, Silver Spring, MD

Abstract Disclosures

Abstract:

Background: Docetaxel is a common comparator arm to test novel therapies in post-platinum mNSCLC trials. The advent of Real World Evidence (RWE) has renewed interest in the use of synthetic control arms (control arms from previously conducted randomized trials) to improve accrual to trials and increase patient access of promising experimental agents. We reviewed legacy second-line (2L) mNSCLC trials to assess the impact of switching docetaxel control arms from one trial to another and compare to an experimental regimen. Methods: We identified 5 contemporary 2L trials that enrolled 2013 patients receiving an experimental therapy vs. docetaxel: 5 immunoncology head-to-head trials (one with 2 arms) and one anti-VEGF add-on trial. Kaplan-Meier curves of overall survival (OS) and progression-free survival (PFS) were produced for docetaxel controls. We calculated OS and PFS hazard ratios and 95% confidence intervals for each synthetic trial. A pooled doc arm was also compared with each experimental agent. Results: See Table. Conclusions: Both individual and pooled docetaxel switching of control arms approximated the original OS HR and 95% CI. Methods such as bootstrapped sampling and propensity score matching will be performed in an effort to more closely approximate the original trial characteristics.

NOriginal OS HR (95% CI)Range of Switch doc OS HR (Range of 95% CI)Pooled doc OS HR (95% CI)
Trial 12920.75 (0.62, 0.91)0.71 – 0.86 (0.58 – 1.02)0.79 (0.67, 0.92)
Trial 21440.68 (0.51, 0.89)0.64 – 0.75 (0.50 – 0.94)0.69 (0.55, 0.85)
Trial 36130.79 (0.68, 0.90)0.65 – 0.71 (0.54 – 0.88)0.69 (0.61, 0.78)
Trial 43440.73 (0.59, 0.89)0.78 – 0.87 (0.64 – 1.05)0.80 (0.69, 0.94)
Trial 53460.63 (0.51, 0.78)0.67 – 0.75 (0.55 – 0.91)0.69 (0.59, 0.82)
Trial 66180.86 (0.75, 0.98)0.79 – 0.96 (0.66 – 1.10)0.89 (0.79, 1.00)

 
Other Abstracts in this Sub-Category:

 

1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

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