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Annals of Oncology ; 32:S1325, 2021.
Article in English | EMBASE | ID: covidwho-1446385

ABSTRACT

Background: OSE2101 (Tedopi®) is an anticancer vaccine (modified epitopes restricted to HLA-A2+ from 5 tumor-associated antigens). Atalante-1 is a randomized phase 3 trial of OSE2101 vs Standard of Care (SoC docetaxel or pemetrexed) in pretreated HLA-A2+ patients with advanced NSCLC, with IO as last treatment. Methods: EGFR and ALK negative NSCLC patients, ECOG PS 0-1 were randomized 2:1 to receive OSE2101 subcutaneously Q3W for 6 cycles, followed by maintenance Q8W for 1 year and Q12W until progression, versus SoC (docetaxel or pemetrexed Q3W). Primary endpoint was OS (initial hypothesis of HR 0.7 for 401 pts). Secondary endpoints were disease control rate (DCR), quality of life (QoL - EORTC QLQ-C30/LC13), and Progression free survival (PFS). Toxicities were reported using CTCAE 5.0. Positive pre-specified analyses (ESMO 2020 #1260MO) identified a Population of Interest (PoI) comprised by patients with IO secondary resistance defined as failure after a minimum of 12 weeks IO in sequential CT-IO patients. Due to the risk of COVID-19 pandemic on data integrity, the study was stopped prematurely following IDMC recommendations. PoI was chosen as primary population for the final analysis. Results: 219 pts were enrolled: median age 65 years, 29% female, 10% never-smoker, 70% non-squamous. 183 (84%) pts received sequential CT-IO from whom 118 pts (54%) complied with the definition of PoI, with otherwise similar characteristics that the overall population. In PoI, mOS was 11.1 mo for OSE2101 vs 7.5 for SoC [HR 0.59 (0.38-0.91) p= 0.02]. 6 mo-DCR 25% vs 24% (NS), mPFS 2.7 mo vs 3.4 (NS), ORR 8% vs 18% (p=0.07). Post progression survival was 7.7 mo vs 4.6 [HR 0.46 p= 0.004], time to worsening ECOG PS 8.6 mo vs 3.3 [HR 0.45 p= 0.0005]. In the total population, HR for OS was 0.86 (0.62-1.19) p=0.36. QoL Global Health Status was maintained for OSE2101 (p<0.05). Severe Adverse Events were 38% vs 68% (p<0.001). There was no TEAE of concern in the OSE2101 group. Conclusions: OSE2101 had a favorable benefit/risk of versus SoC in advanced HLA-A2+ NSCLC patients. HR for OS improved from 0.86 to 0.59 in patients with secondary resistance to IO with a meaningful gain of median OS of 3.6 months with OSE2101. Clinical trial identification: EudraCT 2015-003183-36;NCT02654587. Editorial acknowledgement: We thank Pierre Attali (Medical Expert, MD), François Montestruc (Statistics, eXYSTATt) and Berangere Vasseur (MD, OSE Immunotherapeutics) for their support in the writing of the abstract. Legal entity responsible for the study: OSE Immunotherapeutics. Funding: OSE Immunotherapeutics. Disclosure: B. Besse: Financial Interests, Institutional, Research Grant: AbbVie;Financial Interests, Institutional, Research Grant: Amgen;Financial Interests, Institutional, Research Grant: AstraZeneca;Financial Interests, Institutional, Research Grant: BEIGENE;Financial Interests, Institutional, Research Grant: Blue Print Medicines;Financial Interests, Institutional, Research Grant: BMS;Financial Interests, Institutional, Research Grant: Boehringer Ingelheim;Financial Interests, Institutional, Research Grant: Cellgene;Financial Interests, Institutional, Research Grant: Cristal Therapeutics;Financial Interests, Institutional, Research Grant: Daiichi Sankyo;Financial Interests, Institutional, Research Grant: Eli Lilly;Financial Interests, Institutional, Research Grant: GSK;Financial Interests, Institutional, Research Grant: Inivata;Financial Interests, Institutional, Research Grant: Janssen;Financial Interests, Institutional, Research Grant: Onxeo;Financial Interests, Institutional, Research Grant: OSE Immunotherapeutics;Financial Interests, Institutional, Research Grant: Pfizer;Financial Interests, Institutional, Research Grant: Roche-Genentech;Financial Interests, Institutional, Research Grant: Sanofi;Financial Interests, Institutional, Research Grant: Takeda;Financial Interests, Institutional, Research Grant: Tolero Pharmaceuticals;Financial Interests, Institutional, Research Grant: 4D Pharma;Financial Interests, Institutional, Res arch Grant: Aptitude Health;Financial Interests, Institutional, Research Grant: Cergentis. M.R. Garcia Campelo: Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Advisory Board: Bristol-Myers;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: Boehringer Ingelheim;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Lilly;Financial Interests, Personal, Advisory Board: Takeda;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Personal, Advisory Role: MSD;Financial Interests, Personal, Advisory Role: Bristol-Myers;Financial Interests, Personal, Advisory Role: Roche;Financial Interests, Personal, Advisory Role: Boehringer Ingelheim;Financial Interests, Personal, Advisory Role: Pfizer;Financial Interests, Personal, Advisory Role: Novartis;Financial Interests, Personal, Advisory Role: AstraZeneca;Financial Interests, Personal, Advisory Role: Lilly;Financial Interests, Personal, Advisory Role: Takeda;Financial Interests, Personal, Advisory Role: Janssen;Financial Interests, Personal, Invited Speaker: MSD;Financial Interests, Personal, Invited Speaker: Bristol-Myers;Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim;Financial Interests, Personal, Invited Speaker: Pfizer;Financial Interests, Personal, Invited Speaker: Novartis;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Invited Speaker: Lilly;Financial Interests, Personal, Invited Speaker: Takeda;Financial Interests, Personal, Invited Speaker: Janssen. E. Quoix: Financial Interests, Personal, Speaker’s Bureau: Shugaï;Financial Interests, Institutional, Principal Investigator: Roche;Financial Interests, Institutional, Principal Investigator: OSE Immunotherapeutics;Financial Interests, Institutional, Principal Investigator: Novartis;Financial Interests, Institutional, Principal Investigator: BMS;Financial Interests, Institutional, Principal Investigator: GSK. E. Felip: Financial Interests, Personal, Advisory Board: Amgen;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Advisory Board: BeiGene;Financial Interests, Personal, Advisory Board: Boehringer Ingelheim;Financial Interests, Personal, Advisory Board: Bristol Myers Squibb;Financial Interests, Personal, Advisory Board: Eli Lilly;Financial Interests, Personal, Advisory Board: F. Hoffmann-La Roche;Financial Interests, Personal, Advisory Board: GlaxoSmithKline;Financial Interests, Personal, Advisory Board: Janssen;Financial Interests, Personal, Advisory Board: Medical Trends;Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme;Financial Interests, Personal, Advisory Board: Merck Serono;Financial Interests, Personal, Advisory Board: PEPTOMYC;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Puma;Financial Interests, Personal, Advisory Board: Regeneron;Financial Interests, Personal, Advisory Board: Sanofi;Financial Interests, Personal, Advisory Board: Syneos Health;Financial Interests, Personal, Advisory Board: Takeda;Financial Interests, Personal, Speaker’s Bureau: Amgen;Financial Interests, Personal, Speaker’s Bureau: AstraZeneca;Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb;Financial Interests, Personal, Speaker’s Bureau: Eli Lilly;Financial Interests, Personal, Speaker’s Bureau: F. Hoffmann-La Roche;Financial Interests, Personal, Speaker’s Bureau: Janssen;Financial Interests, Personal, Speaker’s Bureau: Medscape;Financial Interests, Personal, Speaker’s Bureau: Merck Sharp & Dohme;Financial Interests, Personal, Speaker’s Bureau: Merck Serono;Financial Interests, Personal, Speaker’s Bur au: PeerVoice;Financial Interests, Personal, Speaker’s Bureau: Pfizer;Financial Interests, Personal, Speaker’s Bureau: Springer;Financial Interests, Personal, Speaker’s Bureau: Touch Medical;Financial Interests, Personal, Other, Independent Member of the Board: Grifols;Non-Financial Interests, Institutional, Research Grant: Grant For Oncology Innovation (GOI);Non-Financial Interests, Institutional, Research Grant: Fundación Merck Salud. F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker: AZ;Financial Interests, Personal, Invited Speaker: MSD;Financial Interests, Personal, Invited Speaker: BMS;Financial Interests, Personal, Invited Speaker: Pfizer;Financial Interests, Personal, Invited Speaker: Takeda;Financial Interests, Personal, Invited Speaker: Lilly;Financial Interests, Personal, Invited Speaker: Bayer;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: AZ;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Advisory Board: BMS;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Takeda;Financial Interests, Personal, Advisory Board: Lilly;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Advisory Board: Amgen;Financial Interests, Personal, Advisory Board: Sanofi. F. Denis: Financial Interests, Personal, Invited Speaker: Merck;Financial Interests, Personal, Invited Speaker: Chugai;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Invited Speaker: Roche. W. Hilgers: Financial Interests, Personal, Advisory Role: Janssen;Financial Interests, Personal, Advisory Role: AstraZeneca;Financial Interests, Personal, Invited Speaker: MSD. S. Viteri: FinancialInterests, Personal, Full or part-time Employment: Pangaea Oncology;Financial Interests, Personal, Advisory Board: AbbVie;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: BMS;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Institutional, Research Grant: Roche;Financial Interests, Institutional, Research Grant: AbbVie;Financial Interests, Institutional, Research Grant: OSE Immunotherapeutics;Financial Interests, Institutional, Research Grant: Merck;Financial Interests, Institutional, Research Grant: Janssen;Financial Interests, Institutional, Research Grant: Boehringer Ingelheim;Financial Interests, Institutional, Research Grant: Boston Pharmaceuticals;Financial Interests, Institutional, Research Grant: Exelexis;Financial Interests, Institutional, Research Grant: Novocure;Financial Interests, Institutional, Research Grant: Medimmune;Financial Interests, Personal, Other, Travel accomodation expenses: Roche;Financial Interests, Personal, Other, Travel accomodation expenses: Merck;Financial Interests, Personal, Other, Travel accomodation expenses: MSD;Financial Interests, Personal, Other, Travel accomodation expenses: BMS;Financial Interests, Personal, Other, Travel accomodation expenses: OSE Immunotherapeutics. W. Schuette: Financial Interests, Personal, Advisory Role: Roche;Financial Interests, Personal, Advisory Role: Lilly;Financial Interests, Personal, Advisory Role: Amgen;Financial Interests, Personal, Advisory Role: Merck. A. Zer: Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Invited Speaker: BMS;Financial Interests, Personal, Invited Speaker: MSD;Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker: Takeda;Financial Interests, Personal, Stocks/Shares: Nixio;Non-Financial Interests, Institutional, Research Grant: BMS. D. Costantini: Financial Interests, Personal, Full or part-time Employment: OSE Immunotherapeutics;Financial Interests, Personal, Stocks/Shares: OSE Immunotherapeutics. R. Dziadziuszko: Financial Interests, Personal, Advisory Role: F. Hoffman- La Roche Ltd;Financial Intere ts, Personal, Advisory Role: AstraZeneca;Financial Interests, Personal, Advisory Role: Pfizer;Financial Interests, Personal, Advisory Role: Novartis;Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme;Financial Interests, Personal, Advisory Role: Foundation Medicine Takeda;Financial Interests, Personal, Advisory Role: Seattle Genetics;Financial Interests, Personal, Advisory Role: Roche;Financial Interests, Personal, Advisory Role: Boehringer Ingelheim;Financial Interests, Personal, Advisory Board: Bayer;Financial Interests, Personal, Principal Investigator: F. Hoffmann-La Roche Ltd;Financial Interests, Personal, Principal Investigator: Merck Sharp & Dohme;Financial Interests, Personal, Principal Investigator: Amgen;Financial Interests, Personal, Principal Investigator: Janssen;Financial Interests, Personal, Principal Investigator: Bristol Myers Squibb;Financial Interests, Personal, Principal Investigator: AstraZeneca;Non-Financial Interests, Institutional, Product Samples: F. Hoffmann-La Roche Ltd;Non-Financial Interests, Institutional, Product Samples: Novartis;Non-Financial Interests, Institutional, Product Samples: Pfizer. All other authors have declared no conflicts of interest.

2.
Annals of Oncology ; 32:S1159, 2021.
Article in English | EMBASE | ID: covidwho-1432924

ABSTRACT

Background: Outcomes and risk factors associated with COVID-19 worsening among cancer patients have previously been reported. However, the actual impact of SARs-Co-V2 infection on the cancer treatment strategy remains unknown. Here, we report the Gustave Roussy (GR) experience, one year after the onset of the pandemic focusing on the impact of COVID-19 in patients with ongoing management of oncohematological disease. Methods: All patients positively tested for SARS-CoV-2 and managed at GR between Mar 14th 2020 and Feb 15th 2021 (data cut-off) have been included. Patients underlying oncohematological disease and COVID19 characteristics have been collected. Cancer and COVID-19 management and outcomes have been assessed. Primary endpoint was the overall impact of COVID-19 on oncological and hematological treatment strategy assessed at 1, 3, 6 and 12 months. Results: At the time of the analysis, 423 patients (median age: 62 years) were found positive for SARS-CoV-2 and managed at GR with a median follow up of 5.6 months (0-13 months). Among them, 284 (67%) were admitted due to COVID-19. Clinical deterioration occurred in 87 patients (21%), 43 patients (10%) were transferred in intensive care unit and 123 (29%) patients died, among which 47 (11%) died from COVID-19. Overall, 329 (78%) patients were on active treatment for underlying oncohematological disease at time of COVID diagnosis. Impact of COVID-19 on cancer treatment strategy in those patients is presented in the Table. The majority (N=268, 81%) had no change in oncological strategy. For those who experienced a delay, median delay in treatment was 21 days (N=99, [1-77]), 30 days (N=15, [15-56]), 7 days (N=8,[3-35]) for systemic treatment, surgery and radiotherapy respectively. [Formula presented] Conclusions: COVID-19 outbreak is associated with a significant mortality in patients with cancer. However, for patients who did not die from COVID-19, we provide the first report supporting that ongoing treatment was maintained or could be resumed in the majority of cases in a timely manner. Legal entity responsible for the study: Gustave Roussy. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

3.
Annals of Oncology ; 32:S1151, 2021.
Article in English | EMBASE | ID: covidwho-1432905

ABSTRACT

Background: The COVID-19 pandemic deeply threatens the rigorous conduct of clinical trials, notably by delaying site initiation visits, patient enrolment, treatment administration, trial-associated procedures, and data monitoring. Unlike most other medical specialties, clinical trials are an integral part of patient care in oncology. Limiting access to clinical trials therefore results in a loss of chance for patients. Methods: In this retrospective single-center study, we collected clinical trial-specific items (including patient-related or trial management-related items) during the first pandemic wave (March– June 2020) and lockdown (March 17th-May 11th) at Gustave Roussy, and compared them to those of the same period in 2019. Results: In March 2020, 84 phase I (P1) and 210 phase II/III (P2/3) trials were open. During the first pandemic wave, 21 (25%) P1 and 20 (9%) P2/3 trials were temporarily halted, following a unilateral sponsor decision in virtually all cases;all but one were industry-sponsored. Despite this, all important metrics of the P1/2 trial activity remained similar to those of 2019, including the number of patients referred for inclusion (599 vs 620), inclusion consultations (215 vs 247), patients starting treatment (130 vs 130), Internal Review Board (IRB) submissions (14 vs 16), and site initiation visits (11 vs 15), all in 2020 vs 2019, respectively. The impact of the first lock-down was more marked on P2/3, with 152 patient inclusions (vs 346 in 2019), 125 randomizations (vs 278), 43 IRB submissions (vs 50) and 34 site initiation visits (vs 40). However, in parallel, 475 patients were included in three “COVID and cancer” trials. Among the 443 P1 and 2851 P2/3 patients, 198 and 628 COVID-19 PCR were performed internally, and five and 15 (2.5%) were positive, respectively. One patient with a community-based COVID-19 died after transfer in intensive care. Conclusions: Cancer clinical trials can, and must be maintained despite challenges brought by COVID-19. Sharing experiences and retrospectively evaluating the impact on patients’ safety and cancer-related outcomes will be critical to durably improve the clinical trials conduct and to anticipate at best challenges brought by future similar crises. Legal entity responsible for the study: Gustave Roussy. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

5.
Clinical Cancer Research ; 26(18 SUPPL), 2020.
Article in English | EMBASE | ID: covidwho-992022

ABSTRACT

Background: The SARS-CoV-2 outbreak in Paris's region significantly affected Gustave Roussy Cancer Center.Previous analyses showed that mortality rate increases with age in the general population. Here, we report theGustave Roussy experience on older patients (OP) with cancer during the SARS-CoV-2 outbreak. Methods: Cancer pts with suspected SARS-CoV-2 infection were admitted at Gustave Roussy starting March 12th.Screening indications have been adapted over the time. All the COVID19 pts positively tested and managed atGustave Roussy between March 14th (1st positive case) and April 15th have been included in a REDCap database.Pts and underlying oncologic and COVID19 diseases characteristics have been collected. Cancer and COVID-19managements and outcomes have been assessed. The primary endpoint of this analysis was the clinicaldeterioration, defined as the need for O2 supplementation of 6l/min, or death of any cause. Results: Among the first 137 cancer pts diagnosed with SARS-CoV-2, 36 patients were aged 70 years (26%). Mostof them were female (61%) with a median age of 75.5 years old. Most frequent underlying cancers were solidtumors (92%) including GI (19%), lung (17%), GYN (14%), and head and neck (14%). Most OP (36%) were ECOGperformance status 2 versus 24% in younger patients (YP). The diagnosis of SARS-CoV-2 infection was made byRT-PCR or thoracic CT scan alone in 97% and 3% of the cases, respectively, in OP and in 92% and 8% in YP. MostOP experienced symptoms prior to testing (92%) compared to YP (80%). Symptoms differed according to age withmore cough with sputum production in OP (14% versus 5%), dyspnea (39% versus 31%), diarrhea (17% versus9%), shivers (8% versus 0%), sore throat (8% versus 4%), and no anosmia or agueusia. The majority of OP werehospitalized (81%) compared to 72% of YP and treated with HCQ/AZI (15;52%) with inclusion in the ONCOVID trial(EudraCT: 2020-01250-21) compared to 25 (35%) YP. They did not receive any IL-6 inhibitor. Only one OP wasadmitted in the ICU (3%). Clinical deterioration occurred in 10 OP (29%). There was no impact of age on clinicalworsening (HR=1.157;95%CI 0.55-2.42;p=0.7). However, age was associated with worse overall survival (OS)(HR=2.45 95%CI 1.02-5.92 ;p=0.0463). Results will be updated at the meeting. Conclusions: OP with cancer had a different disease presentation, same rate of clinical worsening, but worse OSin SARS-CoV-2 infection.

6.
Annals of Oncology ; 31:S998, 2020.
Article in English | EMBASE | ID: covidwho-804937

ABSTRACT

Background: The SARS-CoV-2 outbreak significantly affected Gustave Roussy cancer center. Here, we report the Gustave Roussy experience on older patients (OP) with cancer during the SARS-CoV-2 outbreak. Methods: Cancer pts with suspected SARS-CoV-2 infection were admitted at Gustave Roussy starting March, 12th. Screening indications have been adapted over time. All the COVID-19 pts positively tested and managed at Gustave Roussy between March 14th and April 15th have been included in a redcap database. Pts and underlying oncological and COVID-19 diseases characteristics have been collected. Cancer and COVID-19 managements, and outcomes have been assessed. The primary endpoint of this analysis was the clinical deterioration, defined as the need for O2 supplementation of 6l/min or more, or death of any cause. Results: Among the first 137 cancer pts diagnosed with SARS-CoV-2, 36 patients were aged 70 years old or over (26%). Most of them were female (61%) with a median age of 75.5 years old. Most frequent underlying cancers were solid tumors (92%) including GI (19%), lung (17%), GYN (14%) and head and neck (14%). Most OP (36%) were ECOG Performans status 2 versus 24% in younger patients (YP). The diagnosis of SARS-CoV-2 infection was made by RT-PCR or thoracic CT scan alone in 97% and 3% of the cases, respectively in OP and in 92% and 8% in YP. Most OP experienced symptoms prior to testing (92%) compared to YP (80%). Symptoms differed according to age with more cough with sputum production in OP (14% versus 5%), dyspnea (39% versus 31%), diarrhea (17% versus 9%), shivers (8% versus 0%), sore throat (8% versus 4%) and no anosmia nor agueusia. The majority of OP was hospitalized (81%) compared to 72% of YP and treated with HCQ/AZI (15;52%) compared to 25 (35%) YP with inclusion in the ONCOVID trial (EudraCT: 2020-01250-21). They did not receive any IL-6 inhibitor. Only one OP was admitted in the ICU (3%). Clinical deterioration occurred in 10 OP (29%). There was no impact of age on clinical worsening (HR=1.157;95%CI 0.55-2.42;p=0.7). However age was associated with worse overall survival (OS) (HR=2.45 95%CI 1.02-5.92;p=0.0463). Results will be updated at the meeting. Conclusions: OP with cancer had a different disease presentation, same rate of clinical worsening but worse OS in SARS-CoV-2 infection. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

7.
Annals of Oncology ; 31:S814-S815, 2020.
Article in English | EMBASE | ID: covidwho-801393

ABSTRACT

Background: Tedopi® is an anticancer vaccine with modified neoepitopes restricted to HLA-A2+ targeting five tumor-associated antigens frequently expressed in lung cancer: CEA, HER2, MAGE2, MAGE3 and P53. ATALANTE-1 was a randomized, open-label, 2-Step phase 3 study comparing the efficacy of Tedopi® with standard treatment (SoC) in HLA-A2+ NSCLC patients in 2nd or 3rd line treatment after progression on ICI. Methods: HLA-A2+ NSCLC patients, EGFR and ALK negative, having progressed to platinum-based chemotherapy (CT) and anti-PD(L)1, ECOG PS 0-1 were randomized 2:1 to receive Tedopi® subcutaneously Q3W for 6 cycles, followed by maintenance Q8W up to first year, then Q12W, or SoC (docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W). The Step-1 hypotheses were based on the evaluation of 1y-OS rate (Fleming design: H0 futility boundary at 25%;H1 alternative efficacy: 40% of OS rate at 12 months). Step-2 was a superiority study with OS as primary endpoint. Results: At cutoff of February 2020, 99 patients (Tedopi® n=63;SoC n=36) were randomized and analyzable for Step-1. The 1y-OS was 29/63 (46%) [95%CI 33-59]) in Tedopi® group and 13/36 (36%) [95%CI 21-54] in SoC. The Step-1 endpoint has shown a lower limit of the 95% confidence interval above the futility boundary (25%) with an OS estimate of 10% above the estimate of SoC. Secondary endpoints and subgroup data will be further presented. Grade 3-4 related TEAEs were 11 % in Tedopi® group and 43 % in SoC. There was no related grade 5 TEAE. Related TEAE leading to withdrawal from the study were also less frequent in Tedopi® group (6%) versus SoC (14%). Due to the risk of COVID-19 pandemic on data integrity, following recommendation of the Independent Data Monitoring Committee and Steering Committee, the decision was taken to early terminate the study at Step-1 and definitely stop new accrual while continuing the OS follow-up in all patients. Conclusions: The Step-1 primary endpoint was positively achieved with a 1y-OS rate of 46% and a good safety profile. Step-1 results shown a favorable benefit/risk of Tedopi® over SoC as 2nd or 3rd line treatment in advanced HLA-A2+ NSCLC patients after failure to ICI. Clinical trial identification: EudraCT: 2015-003183-36;NCT02654587. Legal entity responsible for the study: OSE Immunotherapeutics. Funding: OSE Immunotherapeutics. Disclosure: G. Giaccone: Advisory/Consultancy: CStone;Advisory/Consultancy: Novartis;Advisory/Consultancy: Daiichi;Research grant/Funding (institution): Medimunne;Research grant/Funding (institution): Incyte. E. Felip: Advisory/Consultancy: AbbVie;Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca;Advisory/Consultancy: Blueprint Medicine;Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim;Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS;Advisory/Consultancy, Speaker Bureau/Expert testimony: Elli Lilly;Advisory/Consultancy: Guardant Health;Advisory/Consultancy: Janssen;Advisory/Consultancy: Merck KgaA;Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy: Samsung;Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda;Advisory/Consultancy: GSK;Advisory/Consultancy: Bayer;Speaker Bureau/Expert testimony: Medscape;Speaker Bureau/Expert testimony: Prime Oncology;Speaker Bureau/Expert testimony: Touchime;Research grant/Funding (institution): Fundation Merck Salud;Advisory/Consultancy: Grifols. R. Garcia Campelo: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca;H noraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. F. DENIS: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy: Shugai;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Bayer;Advisory/Consultancy: MSD;Advisory/Consultancy, Licensing/Royalties: Sivan. E. Quoix: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Speaker Bureau/Expert testimony: Shugai;Travel/Accommodation/Expenses: Roche;Travel/Accommodation/Expenses: Takeda;Honoraria (self), interview at ASCO 2019: Medscape. A. Madroszyk: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Travel/Accommodation/Expenses: Pfizer;Travel/Accommodation/Expenses: MSD. D. Debieuvre: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD;Honoraria (self), Research grant/Funding (institution): AstraZeneca;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self): Shugai;Advisory/Consultancy, Research grant/Funding (institution): Pfizer;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Research grant/Funding (institution): Lilly;Research grant/Funding (institution): Sandoz;Travel/Accommodation/Expenses: Boehringer Ingelheim. W. Hilgers: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Honoraria (self): MSD;Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen;Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas;Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Roche. T. Moran: Advisory/Consultancy: Roche;Advisory/Consultancy: Boehringer Ingelheim. D. Galetta: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Boehringer Ingelheim;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca. F. Cappuzzo: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. G. Robinet: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZenaca;Advisory/Consultancy: BMS. S. Viteri: Full/Part-time employment: Pangaea Oncology;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie;Honoraria (self), Travel/Accommodation/Expenses: MSD;Research grant/Funding (institution), Travel/Accommodation/Expenses: Ose Immunotherapeutics;Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck KgaA;Research grant/Funding (institution): Janssen;Research grant/Funding (institution): Boehringer Ingelheim;Research grant/Funding (institution): Boston Pharmaceuticals Research grant/Funding (institution): Exelexis;Research grant/Funding (institution): Novocure;Research grant/Funding (institution): MedImmune. N. Peled: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca;Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Bayer;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Lilly;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Foundation Medicine;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Guardian 360;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Genesort;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck KgaA;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): NovellusDx;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda. D. Costantini: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment, Officer/Board of Directors: OSEImmunotherapeutics. R. Dziadziuszko: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca;Honoraria (self): Pfizer;Honoraria (self): Novartis;Honoraria (self): MSD;Honoraria (self): Foundation Medicine;Honoraria (self), Advisory/Consultancy: Takeda;Advisory/Consultancy: Seattle Genetics. B. Besse: Research grant/Funding (institution): AbbVie;Research grant/Funding (institution): Amgen;Research grant/Funding (institution): AstraZeneca;Research grant/Funding (institution): Beigene;Research grant/Funding (institution): Blueprint Medicine;Research grant/Funding (institution): BMS;Research grant/Funding (institution): Boehringer Ingelheim;Research grant/Funding (institution): Cellgene;Research grant/Funding (institution): Cristal Therapeutics;Research grant/Funding (institution): Daichi-Sankyo;Research grant/Funding (institution): Elli-Lilly;Research grant/Funding (institution): GSK;Research grant/Funding (institution): Ignyta;Research grant/Funding (institution): Ipsen;Research grant/Funding (institution): Inivata;Research grant/Funding (institution): Janssen;Research grant/Funding (institution): Merck KgaA;Research grant/Funding (institution): MSD;Research grant/Funding (institution): Nektar;Research grant/Funding (institution): Onxeo;Research grant/Funding (institution): Ose Immunotherapeutics;Research grant/Funding (institution): Pfizer;Research grant/Funding (institution): PharmaMar;Research grant/Funding (institution): Roche-Genentech;Research grant/Funding (institution): Sanofi;Research grant/Funding (institution): Servier;Research grant/Funding (institution): Spectrum Pharmaceuticals;Research grant/Funding (institution): Takeda;Research grant/Funding (institution): Tiziana Pharma;Research grant/Funding (institution): Tolero Pharmaceuticals. All other authors have declared no conflicts of interest.

9.
Respir Med Res ; 78: 100769, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-343140

ABSTRACT

The objective of this document is to formalize a degraded mode management for patients with thoracic cancers in the context of the COVID-19 pandemic. The proposals are based on those of the French High Council for Public Health, on published data outside the context of COVID-19, and on a concerted analysis of the risk-benefit ratio for our patients by a panel of experts specialized on thoracic oncology under the aegis of the French-Language Society of Pulmonology (SPLF)/French-language oncology group. These proposals are evolving (10 April 2020) according to the situations encountered, which will enrich it, and are to be adapted to our institutional organisations and to the evolution of resources during the COVID-19 epidemic. Patients with symptoms and/or COVID-19+ are not discussed in this document and are managed within the framework of specific channels.


Subject(s)
COVID-19/epidemiology , COVID-19/prevention & control , Pandemics , Thoracic Neoplasms/therapy , Antineoplastic Agents/therapeutic use , COVID-19/complications , Chemoradiotherapy/methods , Chemoradiotherapy/standards , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Humans , Mutation , Neoadjuvant Therapy/methods , Neoadjuvant Therapy/standards , Neoplasm Metastasis , Pulmonary Medicine/methods , Pulmonary Medicine/organization & administration , Pulmonary Medicine/standards , Risk Factors , Risk Reduction Behavior , SARS-CoV-2 , Thoracic Neoplasms/epidemiology , Thoracic Neoplasms/genetics , Thoracic Neoplasms/pathology , Thoracic Surgical Procedures/methods , Thoracic Surgical Procedures/standards
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