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Welcome

Attend this session at the
2019 ASCO Annual Meeting!


Session: Head and Neck Cancer

Type: Poster Session

Time: Saturday June 1, 1:15 PM to 4:15 PM

Location: Hall A


Session: Head and Neck Cancer

Type: Poster Discussion Session

Time: Saturday June 1, 4:30 PM to 6:00 PM

Location: S100a

Palbociclib plus cetuximab versus placebo plus cetuximab in platinum-resistant, cetuximab-naive, HPV-unrelated head and neck cancer: A double-blind randomized phase II trial (PALATINUS).

Sub-category:
Advanced Disease

Category:
Head and Neck Cancer

Meeting:
2019 ASCO Annual Meeting

Abstract No:
6013

Poster Board Number:
Poster Discussion Session (Board #2)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 6013)

Author(s): Douglas Adkins, Jin-Ching Lin, Assuntina Gesualda Sacco, Jessica C. Ley, Peter Oppelt, Qi Shen, Kenneth Alan Kern, Holger C. Thurm, Shaw-Ling Wang, Jean-Francois Martini, Justin Hoffman, Bohuslav Melichar, Makoto Tahara; Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO; Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan; University of California San Diego Moores Cancer Center, San Diego, CA; Pfizer Inc, Collegeville, PA; Pfizer Inc, New York, NY; Pfizer Inc, San Diego, CA; Fakultni Nemocnice Olomouc/Onkologicka Klinika, Pavlova, Czech Republic; National Cancer Center Hospital East, Kashiwa, Japan

Abstract Disclosures

Abstract:

Background: Cetuximab monotherapy results in a median overall survival (OS) of approximately 6 months (mo) in platinum-resistant recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). HNSCC unrelated to human papillomavirus (HPV) is driven by hyperactivation of the CDK4/6 and cyclin D1 (CD1) regulatory complex, resulting in cell cycle progression and tumor growth, suggesting that CDK4/6 inhibition can be a rational therapeutic strategy in this setting. Palbociclib (PAL) is a selective CDK4/6 inhibitor that may reverse cetuximab resistance by countering the actions of deregulated CD1. PAL plus an epidermal growth factor receptor inhibitor synergistically reduced cell viability of HPV-unrelated HNSCC cell lines. In a single-arm, multicenter trial of platinum-resistant, cetuximab-naive, HPV-unrelated HNSCC, PAL in combination with cetuximab resulted in a median OS of 9.5 mo. Methods: In a double-blind randomized phase II trial, patients (pts) with platinum-resistant, cetuximab-naïve, HPV-unrelated HNSCC were treated with cetuximab plus either PAL (arm A) or placebo (arm B). Pts were stratified by performance status (PS) and prior immunotherapy (IT). 120 pts were required for 1:1 randomization to have ≥ 80% power to detect a hazard ratio (HR) of 0.6 (corresponding to a median OS of 10 mo in arm A and 6 mo in arm B) using a 1-sided log-rank test P=0.10). Key secondary endpoints included progression-free survival (PFS), adverse events (AEs), and p16 status. Results: Pts (n=125) were randomized (arm A, 65; arm B, 60). PS and prior IT were balanced between the arms. Median (95% CI) follow-up for OS was 15.9 (15.0–19.4) mo. Median OS was 9.7 (7.3–13.9) mo in arm A and 7.8 (6.7–10.6) mo in Arm B (stratified by PS: HR=0.82 [95% CI, 0.54–1.25], P=0.18). Median PFS was 3.9 mo in arm A and 4.6 mo in arm B (stratified by PS: HR=1.00 [0.7–1.5], P=0.5). Hematologic AEs were more common in arm A. Only 11 pts (9%) received IT after being treated on the trial. Conclusions: Among pts with platinum-resistant, HPV-unrelated HNSCC, PAL plus cetuximab resulted in a trend of prolongation of median OS compared with cetuximab. Clinical trial information: NCT02499120

 
Other Abstracts in this Sub-Category:

 

1. Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 6000 First Author: Danny Rischin
Category: Head and Neck Cancer - Advanced Disease

 

2. TPExtreme randomized trial: TPEx versus Extreme regimen in 1st line recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 6002 First Author: Joel Guigay
Category: Head and Neck Cancer - Advanced Disease

 

3. EAGLE: A phase 3, randomized, open-label study of durvalumab (D) with or without tremelimumab (T) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 6012 First Author: Lisa F. Licitra
Category: Head and Neck Cancer - Advanced Disease

 

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