All times are listed in CEST (Central European Summer Time)
1558O - COVID-19 vaccine in participants (ptcpts) with cancer: Subgroup analysis of efficacy/safety from a global phase III randomized trial of the BNT162b2 (tozinameran) mRNA vaccine
- Stephen J. Thomas (Syracuse, United States of America)
Abstract
Background
Patients with cancer are at higher risk of developing COVID-19 disease, adverse outcomes, and increased mortality. Phase III COVID-19 vaccine trials have demonstrated safety/efficacy against COVID-19 and prevented hospitalizations and deaths; however, most excluded ptcpts with cancer. We present phase 3 tozinameran mRNA COVID-19 vaccine trial results from ptcpts with a cancer history at baseline, either ongoing or not, per the Charlson Comorbidity Index and up to 6 months of follow-up.
Methods
Between Jul 2020-Jan 2021, 46429 ptcpts ≥12 y at 152 sites in 6 countries were randomized in a placebo-controlled, observer-blinded trial of 2-dose tozinameran, showing 95% protection against COVID-19 and favorable safety (Polack et al
Results
Of ptcpts ≥16 y, 1647 had a prior diagnosis of cancer and were not on active immunosuppressive treatment (755 M; 892 F; median age 66 y [range 22-91]). Most common solid cancers included breast (n=458), prostate (n=360), and melanoma (n=210). AEs were reported at IRs of 94.0 (vaccine) and 49.3 (placebo) per 100-person-y; most common AEs were reactogenicity events (injection-site pain [IR: 40.2 vaccine; 4.2 placebo]; fatigue [IR: 21.4 vaccine; 7.6 placebo]; pyrexia [IR: 19.8 vaccine; 0.7 placebo]). 1 vaccine ptcpt withdrew due to a vaccine-related AE. No vaccine-related deaths were reported. Among ptcpts ≥12 y with cancer, 3 vaccine and 27 placebo recipients developed COVID-19 from 7 days post-Dose 2; vaccine efficacy (VE) was 89.7% (95% CI 66.5-98.0%). This compares favorably with overall VE of 91.1%. Updated results will be presented.
Conclusions
Tozinameran has similar efficacy/safety in ptcpts with cancer as in the overall population. These results inform tozinameran use in COVID-19 and in future trials in patients with cancer.
Clinical trial identification
NCT04368728.
Editorial acknowledgement
Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and was funded by Pfizer.
Legal entity responsible for the study
Study sponsored by BioNTech, managed by Pfizer.
Funding
Pfizer and BioNTech.
Disclosure
S.J. Thomas: Financial Interests, Personal and Institutional, Research Grant, Advisory role: Pfizer. J.L. Perez: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.P. Lockhart: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S. Hariharan: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. N. Kitchin: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. R. Bailey: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. K. Liau: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. E. Lagkadinou: Financial Interests, Personal, Full or part-time Employment: BioNTech. Ö. Türeci: Financial Interests, Personal, Research Grant: BioNTech. U. Şahin: Financial Interests, Personal, Research Grant: BioNTech. X. Xu: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.S. Dychter: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. C. Lu: Financial Interests, Personal, Full or part-time Employment: Pfizer. W. Gruber: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. All other authors have declared no conflicts of interest.
1559O - Efficacy and toxicity of BNT162b2 vaccine in cancer patients
- Ithai Waldhorn (Haifa, Israel)
Abstract
Background
Efficacy and safety profile of COVID-19 vaccines had been acquired from phase III studies. Nevertheless, cancer patients were not represented in these trials. In 1/2021 mass vaccination of high-risk population, including cancer patients, was initiated in Israel. We aimed to prospectively evaluate efficacy, immunogenicity and safety of BNT162b2 vaccine in cancer patients.
Methods
Cancer patients on active treatment were prospectively enrolled following first dose of BNT162b2 or after a second dose. Serum was collected after each dose and additionally in case of seronegativity. An age-matched cohort of healthcare workers served as controls. Questionnaires regarding sociodemographics and adverse reactions were employed at serum collection. FDA-approved assay was used to assess IgG at all time-points. Patients’ electronic medical records were reviewed for documentation of COVID-19 infection, blood counts, liver enzymes and imaging studies.
Results
The study included 232 cancer patients and 261 controls. Following first dose 29% of patients were seropositive compared with 84% of controls (p<0.001). Following second dose seropositive rate reached 86%. Rate per 1000-person days after first dose were 12.5 for patients and 48.5 for controls. Chemotherapy reduced immunogenicity (OR 0.41 (95%CI 0.17-0.98). In seronegative patients, rate of documented leukopenia reached 39%. No COVID19 cases were documented throughout the study period except two cases following the first dose. Reported adverse events resembled former published studies.
Conclusions
Our results indicate the BNT162b2 appear to be safe and effective in cancer patients. There is a pronounced lag in antibody production compared with non-cancer controls, however seroconversion occurred in most patients after the second dose. Future real-world data is warranted to determine the long-term efficacy of the vaccine with regard to type of anti-cancer treatment.
Legal entity responsible for the study
The authors.
Funding
ICRF.
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant 1558O and 1559O
- Rebecca Lee (Manchester, United Kingdom)
Q&A and live discussion
- Rebecca Lee (Manchester, United Kingdom)
1560O_PR - Prevalence and impact of COVID-19 sequelae on treatment pathways and survival of cancer patients who recovered from SARS-CoV-2 infection
- Alessio Cortellini (London, United Kingdom)
Abstract
Background
The long-term impact of COVID-19 in cancer patients (pts) is undefined.
Methods
Among 2795 consecutive pts with COVID-19 and cancer registered to OnCovid between 01/2020 and 02/2021, we examined clinical outcomes of pts reassessed post COVID-19 recovery.
Results
Among 1557 COVID-19 survivors, 234 (15%) reported sequelae including respiratory symptoms (49.6%), fatigue (41%) and cognitive/psychological dysfunction (4.3%). Persisting COVID-19 sequelae were more likely found in males (p=0.0407) aged ≥65 years (p=0.0489) with ≥2 comorbidities (p=0.0006) and positive smoking history (p=0.0004). Sequelae were associated with history of prior hospitalisation (p<0.0001), complicated disease (p<0.0001) and COVID-19 therapy (p=0.0002). With a median post-COVID-19 follow up of 128 days (95%CI 113-148), multivariable analysis of survival revealed COVID-19 sequelae to be associated with an increased risk of death (HR 1.76, 95%CI 1.16-2.66) after adjusting for sex, age, comorbidities, tumour characteristics, anticancer therapy and COVID-19 severity. Out of 473 patients who were on systemic anticancer therapy (SACT) at COVID-19 diagnosis; 62 (13.1%) permanently discontinued therapy and 75 (15.8%) received SACT adjustments, respectively. Discontinuations were due to worsening performance status (45.1%), disease progression (16.1%) and residual organ disfunction (6.3%). SACT adjustments were pursued to avoid hospital attendance (40%), prevent immunosuppression (57.3%) or adverse events (20.3%). Multivariable analyses showed permanent discontinuation to be associated with an increased risk of death (HR 4.2, 95%CI: 1.62-10.7), whereas SACT adjustments did not adversely affect survival.
Conclusions
Sequelae post-COVID-19 affect up to 15% of patients with cancer and adversely influence survival and oncological outcomes after recovery. SACT adjustments can be safely pursued to preserve oncological outcomes in patients who remain eligible to treatment.
Clinical trial identification
NCT04393974.
Legal entity responsible for the study
Imperial College London.
Funding
Has not received any funding.
Disclosure
A. Cortellini: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: Sun Pharma. D.J. Pinato: Financial Interests, Personal, Advisory Board: ViiV Healthcare; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca. All other authors have declared no conflicts of interest.
1561O - The future of the oncology workforce since COVID-19: Results of the ESMO Resilience Task Force survey series
- Kok Haw Jonathan Lim (London, United Kingdom)
Abstract
Background
The ESMO Resilience Task Force has investigated wellbeing since COVID-19 in relation to work, lifestyle and support factors in oncology professionals globally. We reported on the significant impact of the initial surge of the pandemic on wellbeing and job performance (Banerjee
Methods
Three anonymous online surveys were conducted during the COVID-19 pandemic (S1, Apr/May 2020; S2, Jul/Aug 2020; S3, Feb/Mar 2021). Longitudinal analysis of responses at these timepoints were conducted. Here, we present responses to questions on job demands and resources, and perceived job performance since COVID-19 (JP-CV).
Results
We analysed 3894 individual responses (S1, n=1520; S2, n=942; S3, n=1432): 53% (n=1961/3731) female, 45% (n=1679/3731) =/<40 years, 31% (n=1132/3692) non-white ethnicity, >100 countries. There has been significant increases from S1 to S3 (p<0.001) in feeling overwhelmed with workload (29% vs 45%); COVID-19-related clinical (14% vs 58%) and research (16% vs 64%) work; out-of-hours work (16% vs 41%), shift work (12% vs 26%) and overall working hours (17% vs 47%); and inadequate time for personal/family life (35% vs 45%). 59% (n=1156/1946) were unable to take allocated annual leave. While JP-CV has improved (34% vs 49%, p<0.001), there remained concerns about the negative impact of the pandemic on career development/training (43%), job security (37%) and international fellowship opportunities (76%). Overall, less than half had felt supported by their work management, professional societies or government, and/or had access to wellbeing support services. 25% (n=266/1086) were considering changing their future career with 38% (n=100/266) contemplating leaving the profession.
Conclusions
Since COVID-19, oncology professionals have reported increased job demands, concerns over career development/training and job security, and inadequate time for personal life. There is a real threat of potential attrition in the current workforce. National and international stakeholders must act together to ensure robust recovery plans as we emerge from the COVID-19 crisis.
Legal entity responsible for the study
The authors.
Funding
ESMO.
Disclosure
K.H.J. Lim: Financial Interests, Personal, Invited Speaker, Speaker honorarium: Janssen; Non-Financial Interests, Officer, Trainees committee representative for the North West deanery: Royal College of Physicians (UK); Non-Financial Interests, Officer, Trainees representative at the RCP Patient Safety Committee: Royal College of Physicians (UK); Non-Financial Interests, Officer, ACP representative at the RCP Student and Foundation Doctor Network (SFDN): Royal College of Physicians (UK); Non-Financial Interests, Officer, Trainees committee member: Association of Cancer Physicians (ACP) UK; Non-Financial Interests, Officer, Young Oncologists Committee (YOC): ESMO; Non-Financial Interests, Officer, Resilience Task Force (RTF): ESMO; Other, Currently funded by Wellcome-Imperial 4i Clinical Research Fellowship: Wellcome Trust. K. Punie: Other, Institutional, Other, institution received speaker fees or honoraria for consultancy/advisory roles: AstraZeneca, Eli Lilly, Gilead Sciences, Medscape, MSD, Novartis, Pfizer, Pierre Fabre, Hoffmann La Roche, Mundi Pharma, PharmaMar, Teva, Vifor Pharma; Other, Institutional, Research Grant: Sanofi; Other, Personal, Other, Travel support: AstraZeneca, Novartis, Pfizer, PharmaMar and Roche. C. Oing: Other, Personal, Other, research funding and honoraria: Roche; Other, Personal, Other, travel grant and honoraria: Medac Pharma and Ipsen Pharma; Other, Personal, Other, travel grant: PharmaMar. E. Elez: Other, Personal, Other, personal fees: Hoffman La - Roche, Bristol Myers Squibb, Servier, Amgen, Merck Serono, ArrayBiopharma, Sanof. T.M.S. Amaral: Other, Personal, Other, personal fees: Pierre Fabre and CeCaVa; Other, Personal, Other, personal fees and travel grants: BMS; Other, Personal, Other, grants, personal fees and travel grants: Novartis; Other, Personal, Other, grants: Neracare, Sanofi and SkylineDx. P. Garrido Lopez: Other, Personal, Other, personal fees: Roche, MSD, BMS, Boerhinger-Ingelheim, Pfizer, AbbVie, Novartis, Lilly, AstraZeneca, Janssen, Blueprint Medicines, Takeda, Gilead, and ROVI. M. Lambertini: Other, Personal, Other, Consultant: Roche, AstraZeneca, Lilly and Novartis; Other, Personal, Other, Honoraria: Theramex, Roche, Novartis, Takeda, Pfizer, Sandoz, and Lilly. C.B. Westphalen: Other, Personal, Other, honoraria, travel support and advisory board: Bayer, BMS, Celgene, Roche, Servier, Shire/Baxalta, RedHil, and Taiho; Other, Personal, Other, speaker honoraria: Ipsen; Other, Personal, Advisory Board: GSK, Sirtex, and Rafael. J.B.A.G. Haanen: Other, Personal, Advisory Role, personal fees for advisory role: Neogene Tx; Other, Institutional, Other, grants and fees paid to institution: BMS, MSD, Novartis, BioNTech, Amgen; Other, Institutional, Other, fees paid to institution: Achilles Tx, GSK, Immunocore, Ipsen, Merck Serono, Molecular Partners, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, Third Rock Ventures, Vaximm. C. Hardy: Other, Personal, Other, Director of a private company Hardy People Ltd.: Hardy People Ltd.. S. Banerjee: Other, Institutional, Research Grant: AstraZeneca, Tesaro and GSK; Other, Personal, Other, Honoraria: Amgen, AstraZeneca, MSD, GSK, Clovis, Genmab, Merck Serono, Mersana, Pfizer, Seattle Genetics, and Tesaro. All other authors have declared no conflicts of interest.
Invited Discussant 1560O_PR and 1561O
- Anne-Marie C. Dingemans (Rotterdam, Netherlands)
Q&A and live discussion
- Anne-Marie C. Dingemans (Rotterdam, Netherlands)