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Avelumab (Anti-PD-L1)

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BACKGROUND METHODS Avelumab (anti–PD-L1) in patients with platinum- • SCCHN is one of the most common cancers worldwide1 • Eligible patients were aged ≥18 years with R/M SCCHN of the oral cavity, – HPV status was assessed centrally in all patients using p16 IHC assay – R/M disease develops in approximately 65% of cases; median OS is <1 year1 oropharynx, hypopharynx, or larynx; had received ≥1 line of platinum • Patients received avelumab 10 mg/kg every 2 weeks until progression, • Systemic treatment options for R/M SCCHN include cetuximab (anti–epidermal therapy with disease progression or recurrence within 6 months of the last refractory/ineligible recurrent or metastatic squamous unacceptable toxicity, or withdrawal from trial occurred growth factor receptor monoclonal antibody) + platinum-based chemotherapy dose; measurable disease according to Response Evaluation Criteria in Solid 2 cell carcinoma of the head and neck (R/M SCCHN): or single-agent nonplatinum chemotherapy for platinum-ineligible patients Tumors version 1.1 (RECIST 1.1); and an Eastern Cooperative Oncology Group • A sample size of 150 patients was planned to provide 95% Clopper-Pearson CIs • Anti–PD-1 immune checkpoint inhibitors have proven to be effective treatment performance status (ECOG PS) score of 0 or 1 for an ORR of 10% (95% CI: 5.7%-16.0%) and 20% (95% CI: 13.9%-27.3%) in the case options as monotherapy in platinum-refractory patients, or as monotherapy or in of 15 and 30 responders, respectively results from a phase 1b cohort combination with chemotherapy in first-line R/M SCCHN2-5 • Patients were not selected based on PD-L1 or HPV status • Avelumab, an anti–PD-L1 immune checkpoint inhibitor, has shown clinical – PD-L1+ status was assessed centrally using immunohistochemistry (IHC); 73-10 • Key endpoints: best overall response and PFS (assessed by independent review activity including durable responses in patients with a range of tumor types6-8 pharmDx assay (PD-L1 expression in ≥1% of tumor cells) committee [IRC] and investigator per RECIST 1.1), OS, and safety RESULTS J. Guigay1, K-W. Lee2, M. Patel3, A. Daste4, D. J. Wong5, S. Goel6, M. Gordon7, M. Gutierrez8, • Between 24 April 2015 and 24 November 2015, 153 patients were enrolled and • Immune-related ORR by investigator per modified immune-related response Figure 3. (A) PFS by RECIST 1.1 per IRC and investigator and (B) OS 9 10 11 12 13 14 received avelumab criteria was 13.7% (95% CI: 8.7%-20.2%) A. Balmanoukian , C. Le Tourneau , A. Mita , D. Vansteene , U. Keilholz , P. Schöffski , 100 – Patients had received a median of 2 prior lines of therapy for metastatic or locally A 15 16 17 18 90 IRC Investigator advanced disease (Table 1), and 12 patients (7.8%) were platinum ineligible Figure 1. Time to and duration of response for patients with confirmed objective (N=153) (N=153) H. J. Grote , D. Zhou , M. Bajars , N. Penel 80 • At data cutoff (31 December 2017), median follow-up was 27.9 months response per (A) IRC and (B) investigator Events, n (%) 119 (77.8) 130 (85.0) 1Antoine Lacassagne Cancer Center, FHU OncoAge Université Côte d’Azur, Nice, France; 2Seoul National University Bundang Hospital, Seoul National 70 Median (95% CI), 3 4 (range, 25-32 months), and 10 patients (6.5%) remained on treatment A 60 1.4 (1.4-2.6) 1.8 (1.4-2.7) University College of Medicine, Republic of Korea; Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA; Groupe Hospitalier months 5 6 Saint André, Hôpital Saint André, Bordeaux, France; UCLA Department of Medicine, Los Angeles, California, USA; Montefiore Medical Center PRIME, – Median duration of treatment was 3.0 months (range, 0.5-29.0 months) 50 New York, New York, USA; 7HonorHealth Research Institute, Scottsdale, Arizona, USA; 8Hackensack University Medical Center, Hackensack, New Jersey, PFS (%) 40 9 10 • Based on IRC and investigator assessment, respectively, median time to USA; The Angeles Clinic and Research Institute, Los Angeles, California, USA; Institut Curie, Centre de Lutte Contre le Cancer (CLCC) de Paris, Paris, 30 11 12 response was 2.8 months (range, 1.3-11.0 months) and 3.3 months (range, 1.2-5.5 France; Cedars-Sinai Medical Center, Los Angeles, California, USA; Institut de Cancérologie de l’Ouest, site René Gauducheau, Département d’Oncologie 20 13 14 months); median duration of response was not estimable (95% CI: 4.2 months-not Médicale, Saint Herblain, France; Charité Comprehensive Cancer Institute, Berlin, Germany; Department of General Medical Oncology, Leuven Cancer 10 15 estimable) and not estimable (95% CI: 8.3 months-not estimable; Figure 1) Institute, University Hospitals Leuven and Faculty of Medicine, Research Unit Laboratory of Experimental Oncology, KU Leuven, Leuven, Belgium; Merck 0 KGaA, Darmstadt, Germany; 16Merck Serono Pharmaceutical R&D Co., Beijing, China; an affiliate of Merck KGaA, Darmstadt, Germany;17 EMD Serono Patients 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 18 Months Research & Development Institute, Inc., Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany; Lille University and Oscar Table 1. Key baseline characteristics No. at risk Lambret Cancer Center, Medical Oncology Department, Lille, France IRC 153 62 34 19 16 11 10 9 9 9 9 9 7 6 1 0 Characteristic N=153 Investigator 153 72 48 31 28 20 18 15 15 11 11 11 9 7 1 0 B 100 Median age (range), years 63 (37-91) N=153 90 Events, n (%) 129 (84.3) Sex, n (%) 80 Median (95% CI), months 8.0 (6.5-10.2) Male 125 (81.7) 0 5 10 15 20 25 30 35 40 70 SCOPE Months OS rate (95% CI), % Female 28 (18.3) 60 1-year 35.9 (28.3-43.6) ECOG PS, n (%) Complete reponse Partial response Progressive disease Ongoing response or stable disease End of treatment 50 2-year 17.1 (11.5-23.7) • We report the efficacy and safety data from a cohort of patients with R/M SCCHN OS (%) 0 40 (26.1) B 40 treated with avelumab monotherapy in the phase 1, open-label, multicenter JAVELIN 1 113 (73.9) 30 20 PD-L1 status, n (%) Solid Tumor trial 10 Positive 107 (69.9) 0 Negative 30 (19.6) 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 Not evaluable 16 (10.5) Months No. at risk 153 138 114 92 74 65 53 48 41 33 29 25 24 20 9 2 0 HPV status, n (%) Patients CONCLUSIONS Positive 39 (25.5) • In patients with PD-L1+ (n=107) or PD-L1− (n=30) tumors: Negative 99 (64.7) • Avelumab showed clinical activity and an acceptable safety profile in heavily Missing 15 (9.8) – Median PFS by RECIST 1.1 per IRC was 1.4 months (95% CI: 1.4-2.8 months) vs 1.4 months (95% CI: 1.3-2.7 months) pretreated patients with platinum-refractory/ineligible R/M SCCHN Site of primary tumor, n (%) Hypopharynx 20 (13.1) – Median PFS by RECIST 1.1 per investigator was 1.8 months (95% CI: 1.4-3.5 Larynx 18 (11.8) months) vs 1.5 months (95% CI: 1.3-4.0 months) • Treatment-related adverse events (TRAEs) were grades 1-2 in the majority of cases (73 of Oral cavity 53 (34.6) 0 5 10 15 20 25 30 35 40 – Median OS was 7.9 months (95% CI: 6.1-10.6 months) vs 8.9 months (95% CI: Oropharynx 34 (22.2) Months 6.7-15.0 months) 83 cases; 88%), and a low proportion of patients had grade ≥3 TRAEs (10 of 83; 12.0%) Other* 28 (18.3) • Median immune-related PFS by investigator per modified immune-related • Responses were irrespective of PD-L1 status Prior lines of anticancer therapy for metastatic or locally Figure 2. Confirmed best overall response by PD-L1 and HPV subgroups per response criteria was 2.8 months (95% CI: 2.7-4.1 months) advanced disease, n (%) (A) IRC and (B) investigator 0 22 (14.4) Table 3. Safety overview – Objective response rates (ORRs) were higher in patients with PD-L1+ tumors (n=107; 1 49 (32.0) A Subgroups N Patients ith an objective response n (%) 95% CI* 2 38 (24.8) Overall population 153 14 (9.2) 5.1-14.9 n (%) N=153 ORR by IRC, 10.3%; ORR by investigator, 15.0%) vs PD-L1− tumors (n=30; ORR by IRC, 3 28 (18.3) PD-L1 expression (≥1%) AE* 3.3%; ORR by investigator, 6.7%) and in patients with HPV+ tumors (n=39; ORR by IRC, ≥4 15 (9.8) Positive 107 11 (10.3) 5.2-17.7 Any grade 149 (97.4) Missing 1 (0.7) Negative 30 1 (3.3) 0.1-17.2 Grade ≥3 91 (59.5) 15.4%; ORR by investigator, 17.9%) vs HPV− tumors (n=99; ORR by IRC, 5.1%; ORR by Not evaluable 16 2 (12.5) 1.6-38.3 * Includes salivary glands (n=3), nasal cavity and sinuses (n=2), nasopharynx (n=2), and other (n=21) TRAE HPV status Any grade 83 (54.2) investigator, 11.1%) Positive 39 6 (15.4) 5.9-30.5 Table 2. Confirmed best overall response per IRC and investigator Negative 99 5 (5.1) 1.7-11.4 Grade ≥3 10 (6.5) Unknown 15 3 (20.0) 4.3-48.1 Serious TRAE 6 (3.9) – Progression-free survival (PFS) and overall survival (OS) were similar in both PD-L1+ and N=153 Characteristic 0 10 20 30 40 50 60 70 80 90 100 PD-L1− subgroups IRC Investigator TRAE leading to permanent discontinuation 4 (2.6) B Subgroups N Patients ith an objective response n (%) 95% CI* TRAE leading to death 0 Confirmed best overall response, n (%) Overall population 153 20 (13.1) 8.2-19.5 † Complete response 2 (1.3) 5 (3.3) Immune-related AE Partial response 12 (7.8) 15 (9.8) PD-L1 expression (≥1%) Any grade 23 (15.0) Positive 107 16 (15.0) 8.8-23.1 Grade ≥3 3 (2.0) GET POSTER PDF Stable disease 46 (30.1) 50 (32.7) Negative 30 2 (6.7) 0.8-22.1 Infusion-related reaction‡ GET PLAIN LANGUAGE SUMMARY Noncomplete response/nonprogressive disease 1 (0.7) 0 Not evaluable 16 2 (12.5) 1.6-38.3 Copies of this poster obtained through quick response (QR) code are for personal Any grade 23 (15.0) Progressive disease 67 (43.8) 66 (43.1) use only and may not be reproduced without permission
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  • Adding Cetuximab to Paclitaxel and Carboplatin for First-Line

    Adding Cetuximab to Paclitaxel and Carboplatin for First-Line

    www.nature.com/bjc ARTICLE Clinical Study Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP Gunnar Folprecht1, Karolin Trautmann1, Alexander Stein2, Gerdt Huebner3, Michael Stahl4, Stefan Kasper5, Albrecht Kretzschmar6, Claus-Henning Köhne7, Viktor Grünwald 8,9, Ralf-Dieter Hofheinz10, Katharina Schütte1, Harald Löffler11, Carsten Bokemeyer2, Alwin Krämer12 and Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group BACKGROUND: Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP. METHODS: This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS). RESULTS: One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9–4.8 and 6.8–9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups.