Welcome to ESMO 2020
An overview of the sessions and attendees at ESMO 2020
The Annual Meeting of the European Society of Medical Oncology (ESMO) took place under a new virtual format on 19–21 September 2020, in collaboration with the European Oncology Nursing Society (EONS). Even during a pandemic, efforts to fight cancer do not stop and leading oncology experts from all corners of the world were reunited as one oncology community to share the latest advances in the field at the ESMO Virtual Congress 2020. Indeed, this year’s tagline of ‘Bringing innovation to cancer patients’ was particularly timely in the current era where there is an urgent need to put the latest real-world evidence into clinical practice. The ESMO Virtual Congress 2020 programme provided the first announcements of practice-changing data and ground-breaking translational cancer research that delegates have come to expect from the Society’s annual Congress.
“The ESMO Virtual Congress 2020 is certainly something new and different, but its essence is there: sharing the latest research results to bring innovations to patients with cancer. ”
Solange Peters, ESMO and Congress 2020 President
Gastrointestinal cancers
Hepatic cancer
HAIC vs. TACE in patients with HCC
Currently, transarterial chemoembolisation (TACE) is the standard-of-care for patients with unresectable intermediate-stage hepatocellular carcinoma (HCC). Ming Shi, Sun Yat-sen University, Guangzhou, China, presented data from a Phase III open-label study to show that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (FOLFOX) significantly improved overall survival (OS) compared with TACE in Chinese patients with unresectable HCC.
Patients in the HAIC arm also had a higher overall response rate (ORR) compared with the TACE arm (RECIST: 45.9% vs 17.9%, respectively; p<0.001; mRECIST: 48.4% vs 32.7%, respectively, p=0.004). Median progression-free survival (PFS) was also longer at 9.6 months in the HAIC group compared with 5.4 months in the TACE group. More patients in the HAIC group underwent subsequent resection compared with the TACE group (23.8% [38/159] vs. 11.5% [18/156]; p=0.004). Discussant Lorenza Rimassa, Humanitas University and Humanitas Research Hospital-IRCCS, Milan, Italy, noted that HAIC is not a globally accepted treatment for HCC and is mainly used in China where this trial was conducted, hence more clinical trials are needed to define its true value.
Pancreatic cancer
Data from the Phase II Canadian Cancer Trials Group PA.7 presented by Daniel Renouf, University of British Columbia, Vancouver, Canada, showed that the addition of durvalumab plus tremelimumab to standard-of-care chemotherapy did not improve survival or ORR among patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) (LBA65; NCT02879318). Patients with treatment-naive mPDAC received durvalumab plus tremelimumab with gemcitabine and nab-paclitaxel, or gemcitabine plus nab-paclitaxel alone. Durvalumab plus tremelimumab did not provide additional benefit over chemotherapy for any of the outcomes.
OS in patients with mPDAC treated with durvalumab-tremelimumab vs. chemotherapy
The lack of OS benefit with immunotherapy was consistent across patient subgroups.
“Further studies to assess biomarkers that may predict immune sensitivity in this setting are underway.”
Daniel Renouf, University of British Columbia, Vancouver, Canada
Gastric and oesophageal cancers
New data presented at this year’s meeting have shown that immunotherapy is beneficial for patients with gastric and oesophageal cancers who currently have poor survival. Three studies provided evidence, based on different patient populations and different immune checkpoint inhibitors used as first-line (1L) therapy.
Markus Moehler, Johannes-Gutenberg University Clinic, Mainz, Germany, presented first data from the CheckMate 649 study (NCT02872116), which evaluated nivolumab plus chemotherapy versus chemotherapy alone as 1L treatment in patients with non-human epidermal growth factor receptor 2-positive (HER2+) advanced gastric cancer, gastro-oesophageal junction cancer, or oesophageal cancer – all with adenocarcinoma histology (LBA6_PR). Data show that nivolumab and chemotherapy significantly improved both PFS and OS in the nivolumab plus chemotherapy arm versus chemotherapy alone.
Key findings from the CheckMate 649 study
Median OS was 14.4 months in the nivolumab plus chemotherapy arm versus 11.1 months in the chemotherapy arm (HR 0.71; p<0.0001) [OS survival rates at 12 months of 57% vs 46%, respectively] after a minimum follow-up of 12 months
Superior OS benefit with nivolumab plus chemotherapy was reported in patients with PD-L1 combined positive score (CPS) ≥1 (HR 0.77) and in all randomised patients, irrespective of PD/L1 expression (HR 0.80)
Median PFS in patients with PD/L1 CPS ≥5 was significantly improved by nivolumab: 7.7 months versus 6.0 months, respectively (HR 0.68; p<0.0001)
Key efficacy data in the CheckMate 649 study
These data highlight the potential of nivolumab in combination with chemotherapy as a 1L treatment for patients with HER2-negative gastric adenocarcinoma, oesophageal adenocarcinoma, or gastro-oesophageal junctional adenocarcinoma with PD-L1 CPS of >5 tumours. The use of this treatment approach in patients who have a PD-L1 CPS <5 remains less clear. Further analysis of subgroups and biomarkers (such as microsatellite instability-high) are planned to better characterise the efficacy benefit in patients across all CPS cut-off groups.
“OS benefit of nivolumab plus chemotherapy was observed in all pre-specified subgroups, including race and region.”
Markus Moehler, Johannes-Gutenberg University Clinic, Mainz, Germany
The results of CheckMate-649 are in line with the results of the Phase III part of the ATTRACTION-4 (ONO-4538-37; LBA7_PR; NCT02746796) study which included Asian patients with previously untreated advanced or recurrent gastric/gastroesophageal junction who received nivolumab plus chemotherapy or chemotherapy alone. Narikazu Boku, National Cancer Center Hospital, Tokyo, Japan, presented data from ATTRACTION-4 to show that 1L treatment with nivolumab plus chemotherapy improved the co-primary PFS endpoint, but not OS.
After a median follow-up of 26.6 months, there was no statistically significant difference in OS in the nivolumab plus chemotherapy versus chemotherapy alone groups (17.5 months vs 17.3 months, respectively; HR 0.90; p=0.257). Commenting on the data presented for CheckMate-649 and ATTRACTION-4, Elizabeth Smythe, Cambridge University Hospitals, Cambridge, UK, suggested that more effective second- (2L) and third-line (3L) treatments in Asia could explain the non-significance of the OS data. In addition, Dr Smythe cautioned not to extrapolate the benefit seen in patients with PD-L1 CPS ≥5 in CheckMate 649 to all patients as the significant benefit seen in all randomised patients was predominantly driven by 60% (955/1581) of patients with PD-L1 CPS ≥5 in the total population.
A separate analysis of patients with PD-L1 CPS <5 should be performed to see whether nivolumab plus chemotherapy is also beneficial for these patients.”
Elizabeth Smythe, Cambridge University Hospitals, Cambridge, UK
Top-line data from the Phase III KEYNOTE-590 study (NCT03189719) presented by Ken Kato, National Cancer Center Hospital, Tokyo, Japan, demonstrated that 1L pembrolizumab plus chemotherapy significantly improved OS, PFS and ORR, compared with chemotherapy alone in patients with locally advanced unresectable or metastatic oesophageal cancer (LBA8_PR).
Moreover, the 12-month OS rate with pembrolizumab plus chemotherapy was 51% versus 39% with chemotherapy alone, while at 24 months these rates were 28% versus 16%, respectively. Median investigator-assessed PFS per RECIST v1.1 criteria was 6.3 months with pembrolizumab plus chemotherapy versus 5.8 months with chemotherapy alone (HR: 0.65; 95% CI: 0.55, 0.76; p<0.0001). At 12 months, the PFS rates in the investigational and control arms were 25% versus 12%, respectively (16% versus 6% at 18 months). Given that the standard-of-care for patients with advanced oesophageal cancer has remained relatively unchanged for a long period of time, these data suggest pembrolizumab plus chemotherapy has the potential for use as a new standard-of-care as 1L therapy in this patient population.
The risk of recurrence after neoadjuvant chemoradiation therapy (CRT) followed by surgery (trimodality therapy) remains high in oesophageal or gastroesophageal junction cancer and there remains no established adjuvant treatment. Ronan Kelly, The Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas, USA, presented a pre-specified interim analysis from CheckMate 577 study (NCT02743494) which showed adjuvant nivolumab to be the first therapeutic to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus placebo in patients with resected oesophageal or gastroesophageal junction cancer who had previously received neoadjuvant CRT (LBA9_PR).
CheckMate 577 study: Median DFS was doubled with nivolumab
Adjuvant nivolumab showed a statistically significant improvement in DFS versus placebo of 22.4 versus 11.0 months, respectively (HR 0.69; 96.4% CI: 0.56, 0.86; p=0.0003)
DFS improvements shown with adjuvant nivolumab in patients with resected oesophageal or gastroesophageal junction cancer
These data represent the first treatment advance in many years for these patients, with adjuvant nivolumab having the potential to be established as a new standard-of-care.
Closing Remarks
In summary, ESMO 2020 was a successful virtual meeting with delegates having had the chance to remotely access new data, clinical experiences, patient perspectives, and best practices that will hopefully stimulate new ways of thinking and ultimately translate into optimal patient care within the oncology field. In addition, with the ongoing COVID-19 pandemic and the shift to distance learning and virtual meetings, ESMO acknowledged this opportunity to further extend their educational reach by providing accessible virtual content to physicians located in regions far removed from the cancer conference circuit.
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