This year´s ESMO Congress, celebrated 08 – 12 September in Madrid, attracted a record attendance of almost 24,000 participants from 131 countries with 1,736 abstracts selected for presentation and 55 that showcased as late breaking. As testament to the quality of the cancer science and clinical findings reported throughout the meeting, research was simultaneously published in top tier journals including The New England Journal of Medicine, The Lancet Oncology, and ESMO´s flagship journal Annals of Oncology.
Held in collaboration with the European Association for Cancer Research (EACR), the Congress´ Scientific Program of excellence, coupled with a star cast of eminent speakers from across the globe delivered a perfect balance and blend of the very latest insights into precision cancer research, treatment and care, with a second-to-none fully integrated Patient Advocate Track.
Delivering a Keynote Lecture entitled Coping with Escalating Healthcare Costs in 2017 and Beyond, Josep Tabernero, VHIO´s Director, Head of the Vall d´Hebron University Hospital (HUVH), and President-elect of ESMO, discussed current trends and statistics, highlighted ESMO action focused on tackling the skyrocketing costs of oncotherapeutics and supportive care drugs, raised some essential policy points, and road mapped key directions that all stakeholders should collectively follow if we are to reduce the global socioeconomic burden of cancer – now and in the future.
More specifically, he reviewed the milestones marked to-date by ESMO´s Cancer Medicines Working Group and Policy Committee, highlighted the importance of major value-based frameworks, including ESMO´s Magnitude of Clinical Benefit Scale in upholding the proven as opposed to promising in assessing the performance and cost-benefit of novel cancer medicines in achieving improved outcomes for patients, and discussed the importance of safeguarding academic clinical cancer research of excellence through initiatives including the EACR-EORTC-ESMO Clinical Academic Cancer Research Forum (CAREFOR).
In addition, he stressed the need to fully embrace the advent of biosimilars and updated on ESMO´s activities aimed at promoting them as essential, more accessible anti-cancer weaponry, including a Session at the European Commission Stakeholder Event on Biomedicinal Products in May 2017, and a Special Session during the Congress entitled The incoming wave of biosimilars in oncology, which he co-chaired alongside Elena Wolff-Holz, Senior Medical Assessor, Paul Ehrlich Institut (Germany), and Member of EMA´s Biosimilar Medicinal Products Working Group.
Wrapping up his Keynote, Tabernero emphasised the importance of acting in unison and engaging the entire oncology ecosystem in order to ensure that an increasing number of patients can access the very best cancer medicines.
“Only together will we potentiate our therapeutic and prevention strategies by turning current challenges into opportunity and better outcomes for those who matter most – our patients”, he concluded.
The promise of novel antibody combination Sym004
A study presented by Josep Tabernero during a Proffered Paper Session on Gastrointestinal tumours (colorectal), Efficacy and safety of Sym004 in refractory metastatic colorectal cancer with acquired resistance to anti-EGFR therapy: Results of a randomized phase II study (RP2S), assessed the performance of Sym004 – a duo of monoclonal antibodies developed as anti-cancer therapy for tumours that had developed resistance to EGFR inhibitors.
The trial aimed at establishing both the optimal dose of this drug and its efficacy compared with other treatments. The results showed that a less concentrated dose, 9 mg/kg, followed by a second dose of 6 mg/kg, was not only better tolerated than a single 12 mg/kg dose, but also improved overall survival in patients. The study also revealed that SYM004 has a significant response compared with any fourth-line treatment of metastatic colorectal cancer, and in view of the promising results in the molecularly selected population, will be used in the design of ctDNA-guided trials in EGFR inhibitor refractory metastatic colorectal cancer.
New therapeutic avenue for ER-positive, HER2-negative early breast cancer
Primary results of LORELEI: A phase II randomized, double-blind study of neoadjuvant letrozole (LET) plus taselisib versus LET plus placebo (PLA) in postmenopausal patients (pts) with ER+/HER2-negative early breast cancer, were presented by Cristina Saura, Principal Investigator of VHIO´s Breast Cancer and Melanoma Group during a Proffered Paper Session on Breast Cancer (early stage).
Carried out in essential collaboration with academic partners the Breast International Group (BIG), SOLTI Breast Cancer Research Group, and the Austrian Breast & Colorectal Cancer Study Group (ABCSG), and conducted in 85 sites across the world, the LORELEI study, led by Cristina, assessed the efficacy of adding taselisib to letrozole before surgery for the treatment of patients with operable early estrogen receptor positive and HER2-negative breast cancer.
The results of this very first randomized study to demonstrate a marked increase in objective response rate (ORR) upon treatment with a PI3K selective inhibitor showed that the administration of taselisib and letrozole prior to surgery significantly improved outcomes for this population of patients compared with treatment with letrozole alone. According to Cristina, “Adding taselisib to letrozole increased ORR from 38% to 56.2% in patients with a PIK3CA gene mutation and from 39.3% to 50% in all patients enrolled in the study. Importantly, we also detected a reduction in tumor size after only 16 weeks of treatment, compared with patients who received letrozole plus placebo”.
“Studies conducted with samples taken from the patients treated in this trial will help us enormously to better develop taselisib for the treatment of estrogen receptor-positive breast cancer”, she observed.
JACOB study for the treatment of HER2-positive metastatic gastric cancer
During a Proffered Paper Session on Gastrointestinal tumours (non-colorectal), Josep Tabernero, in collaboration with other international investigators, presented the final analysis of the phase III JACOB trial: Pertuzumab + trastuzumab + chemotherapy for HER2-postiive metastatic gastric or gastro-oesophageal junction cancer.
The study explored the possibility of combined treatment with pertuzumab and trastuzumab, two monoclonal antibodies, together with chemotherapy for patients with HER2-positive metastatic gastric cancer. The benefits of this trio of therapies have previously been evidenced in HER2+ breast tumours.
From June 2013 to January 2016 the study enrolled a total of 780 patients who were divided into two groups. One group received pertuzumab and trastuzumab plus chemotherapy, and for the second group pertuzumab was replaced by a placebo. Although the study failed to demonstrate a statistically improvement in overall survival with the addition of pertuzumab to trastuzumab, a median increase of 3.3 months in overall survival was observed in the first group.
“Although these results showed less benefit than expected, they suggest that this combination should be further studied in a more select population of patients with HER2+ metastatic gastric cancer and gastroesophageal junction cancer”, commented Tabernero.
VHIO: accelerating cancer discovery through the integration of translational and clinical research
Among the many other accepted abstracts first-authored by VHIO faculty, presented as orals and posters, one in particular reflects the theme of this year´s ESMO Congress: Integrating Science into Oncology for a Better Patient Outcome, and is also representative of VHIO´s purely multidisciplinary and translational approach to rendering cancer treatment and care more precise.
Presented as a poster by first author Cinta Hierro, Phase I Investigator of VHIO´s Early Clinical Drug Development Group, under the category of Translational Research, a multi-VHIO group collaboration, along with colleagues at the Catalan Institute of Oncology (ICO) – Bellvitge Biomedical Research Institute (IDIBELL), sought to establish a translational research framework for FGFR-altered patients treated with fibroblast growth factor receptor inhibitors towards ultimately reversing resistance to FGFR targeting.
This VHIO tour de force, incorporating the expertise of its Early Clinical Drug Development, Experimental Therapeutics, Oncology Data Science (ODysSey), Molecular Oncology, Stems Cells and Cancer, Growth Factors, and Cancer Genomics Groups, successfully developed a powerful precision medicine framework for linking molecular biology with the best tumor models in parallel with early clinical research.
“By generating a collection of patient samples with molecularly-selected FGFR-altered tumors and developing a protocol to obtain serial biopsies during therapy with these inhibitors for patient-derived xenografts (PDXs) generation, insights obtained from the samples as well as analysis of circulating tumor DNA will be applied to validating future hypothesis-driven therapies and more effectively developing FGFR inhibitors matched to the specificities these patients”, said Cinta Hierro.
“We are increasingly witnessing how multidisciplinary cross-talk and close collaboration between preclinical scientists and clinical investigators is driving faster progress in our collective efforts aimed at improving outcomes for our patients. This year´s ESMO Congress, organized in collaboration with EACR, serves as a case in point”, noted Elena Garralda, Principal Investigator of VHIO´s Early Clinical Drug Development Group and Executive Director of the Research Unit for Molecular Therapy of Cancer (UITM) – “la Caixa”, who delivered an invited talk entitled Accelerated clinical evaluation of drug combinations based on biological insight, during the Congress´ ESMO-EACR Joint Symposium: Preclinical models for developing combination therapeutics.
´Found´ in Translation
This year´s ESMO Congress was organized for the very first time in partnership with the European Association for Cancer Research (EACR), and superbly delivered the necessary balance and blend of preclinical, translational and clinical interest to ensure ´global´ and multidisciplinary appeal – from the bench to the bedside and back.
ESMO consequently provided both the platform and the invaluable opportunity for clinicians to acquire the very latest preclinical insights and scientists to be fully updated on new treatment outcomes, and as importantly, to come together to collectively explore current challenges and roadmap next directions towards more speedily advancing personalized and targeted therapies against cancer.
It is thanks to the inspired vision and dedication of Fortunato Ciardiello, ESMO and Congress President, Alberto Sobrero, ESMO Scientific Committee Co-Chair, Richard Marais, EACR Scientific Committee Co-Chair, along with the expertise and hard work of the many other Track Chairs and appointed experts, including EACR´s President Anton Berns, who co-chaired the Basic Science Track with Christof von Kalle, and Joan Seoane, EACR Secretary General and Director of Translational Research at VHIO, who co-chaired the Translational Research Track alongside Charles Swanton, ESMO representative and EACR Member, that this year´s ESMO Congress par excellence delivered on Integrating science into oncology for a better patient outcome.
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