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2019 ASCO Annual Meeting!

Session: Melanoma/Skin Cancers

Type: Oral Abstract Session

Time: Tuesday June 4, 9:45 AM to 12:45 PM

Location: S406

FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type.

Advanced Disease

Melanoma/Skin Cancers

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 9508)

Author(s): Christy Osgood, Flora Mulkey, Pallavi Shruti Mishra-Kalyani, Steven Lemery, Ashley Ward, Patricia Keegan, Rajeshwari Sridhara, Marc Robert Theoret, Richard Pazdur; U.S. Food and Drug Administration, Silver Spring, MD

Abstract Disclosures


Background: Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 may not capture the full spectrum of benefit that patients with melanoma derive from targeted kinase inhibitors (TKI) or immunotherapies. We explored the relationship between DpR and overall survival (OS) in patients treated with TKI (BRAF, MEK inhibitors), immunotherapy (antibodies targeting PD-1 or CTLA-4), or chemotherapy (dacarbazine or paclitaxel). Methods: Ten randomized controlled trials of patients with previously untreated UMM were pooled and evaluated by type of therapy. DpR was grouped by maximal tumor shrinkage (G0 = no shrinkage or increase, G1 = ≤25%, G2 = 26-50%, G3 = 51-75%, G4 = 76- < 100%, and G5 = 100%). We performed an exploratory analysis evaluating the association between DpR and OS using hazard ratios (HR) generated from a Cox proportional hazards model where maximal tumor shrinkage category was included as a time varying covariate. Results: There were 3778 patients evaluable for tumor response. The table displays the HR for OS by DpR group and therapy type. Estimated OS at 24m in patients with deep response ( > 75%; G4+G5) treated with TKI and immunotherapy was 69% and 92%, respectively, although many patients were censored. Conclusions: For patients with previously untreated UMM a larger DpR correlates with a longer OS, regardless of therapy type. Deep response ( > 75%) is associated with a high rate of estimated OS at 24 months in patients treated with immunotherapy. Analysis of DpR provides additional granularity of response data and may provide a more nuanced prediction of clinical outcome.

n (%); HR (95% CI)
n (%); HR (95% CI)
n (%); HR (95% CI)
G1 vs. G0299 (13%); 0.41 (0.32, 0.53)166 (11%); 0.61 (0.46, 0.82)78 (16%); 0.61 (0.37, 0.99)
G2 vs. G0569 (25%); 0.26 (0.20, 0.33)207 (14%); 0.49 (0.38, 0.64)59 (12%); 0.33 (0.17, 0.65)
G3 vs. G0644 (28%); 0.15 (0.11, 0.21)202 (14%); 0.33 (0.26, 0.43)25 (5%); 0.21 (0.07, 0.65)
G4 vs. G0294 (13%); 0.10 (0.06, 0.16)147 (10%); 0.22 (0.16, 0.31)12 (2%); not evaluable
G5 vs. G0286 (12%); 0.06 (0.03, 0.10)234 (16%); 0.14 (0.09, 0.20)11 (2%); not evaluable

Other Abstracts in this Sub-Category:


1. Phase 3 international trial of adjuvant whole brain radiotherapy (WBRT) or observation (Obs) following local treatment of 1-3 melanoma brain metastases (MBMs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9500 First Author: Gerald Fogarty
Category: Melanoma/Skin Cancers - Advanced Disease


2. Efficacy and safety of the combination of nivolumab (NIVO) plus ipilimumab (IPI) in patients with symptomatic melanoma brain metastases (CheckMate 204).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9501 First Author: Hussein Abdul-Hassan Tawbi
Category: Melanoma/Skin Cancers - Advanced Disease


3. Salvage therapy after failure from anti-PD-1 single agent treatment: A Study by the German ADOReg melanoma registry.

Meeting: 2019 ASCO Annual Meeting Abstract No: 9505 First Author: Michael Weichenthal
Category: Melanoma/Skin Cancers - Advanced Disease