ESMO 2016 highlights

Written by Stephen Dunn – Healthcare Director

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The 2016 ESMO Annual Meeting in Copenhagen was as busy as ever and we interviewed over 60 experts who presented important results this year in various fields, including lung cancer, breast cancer, renal-cell carcinoma, melanoma and prostate cancer. We have summarized our key highlights below.

How pembrolizumab will change the management of advanced lung cancer

The results of the Phase III KEYNOTE-024 trial of pembrolizumab for non-small cell lung cancer (NSCLC) were presented by VJOncology Editorial Board Member Dr Martin Reck of LungenClinic Grosshansdorf.

The Phase III KEYNOTE-024 trial assessed pembrolizumab compared to standard of care (SOC) platinum-based chemotherapies in patients with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) high expressing NSCLC.

The primary endpoint was progression-free survival (PFS), which was in favor of pembrolizumab with a prolongation of median PFS from 6 months to 10.3 months. There was also an improvement in overall survival (OS) as well as an improvement in response. Further, the tolerability was in favor of pembrolizumab.

We talked Dr Martin Reck about the trial. He explains that “this data will completely change our management of patients with advanced lung cancer”. In light of these findings, it is important to screen patients for PD-L1 expression and for those patients with high PD-L1 expression, pembrolizumab will be an option for first-line therapy.

FALCON trial of fulvestrant for advanced breast cancer

The Phase III FALCON trial compared fulvestrant to anastrozole for hormone receptor-positive advanced breast cancer.

Prof. Matthew Ellis from the Baylor College of Medicine presented the trial and talked to us about its design, the results and implications. In the interview, he explains that the study was designed to address the question if there is an optimal first-line endocrine therapy for patients with hormone receptor-positive advanced breast cancer who had not been treated with a hormonal agent before.

The primary endpoint of the study was progression-free survival (PFS); Prof. Ellis highlights that “patients on fulvestrant stayed on the drug in response approximately three months longer than patients on anastrozole” (16.6 months vs 13.8 months).

Prof. Ellis further points out that the results were statistically significant but the question is, if they are clinically significant. He explains that these kinds of differences as observed in this trial, have driven changes in clinical practice before as in the case of tamoxifen and aromatase inhibitors.

No surprises: results from the ENGOT-OV16/NOVA trial of niraparib in ovarian cancer

The ENGOT-OV16/NOVA trial of niraparib was a randomized, double-blinded placebo study with women with relapsed platinum-sensitive high-grade ovarian cancer.

We talked to Dr Ursula Matulonis of the Dana-Farber Cancer Institute, who co-authored the abstract presented at ESMO. She explains that the women on the trial underwent germline BRCA testing and were grouped into gBRCA and non-gBRCA cohort; in the latter cohort, they were further tested for homologous recombination deficiency (HRD).

In all the groups, there was a benefit to receiving niraparib and this is not a surprising result as Dr Matulonis explains, as all the patients with epithelial ovarian cancer were distilled “into the group that’s going to benefit most from a PARP inhibitor”. She highlights that the results are very exciting and that “it is the first Phase III trial to be reported of a PARP inhibitor and showing really quite significant progression-free survival benefit”.

CABOSUN trial of cabozantinib – could it change how we treat frontline renal-cell carcinoma?

In the CABOSUN trial, cabozantinib was compared to sunitinib in treatment naive poor and intermediate risk renal-cell carcinoma (RCC) patients.

The primary endpoint was PFS and the researchers observed a PFS benefit that they think is “clinically relevant and statistically significant,” as Dr Toni Choueiri of the Dana-Farber Cancer Institute highlights. Further, there was a 31% decrease in risk of progression of death. Also, the secondary endpoint, response rate, was higher and more significant with cabozantinib. Dr Choueiri, who presented the results at ESMO 2016, explains, they also had an early look at overall survival (OS), which is not significant yet but trending in the right direction.

The side effects were similar in both arms and in our interview, Dr Choueiri poses the question if cabozantinib could become the next first-line option after sunitinib, which was the standard and most used first-line agent for ten years. He believes that cabozantinib could become the next first-line option and therefore “it is very possible that this study will change how we treat frontline renal cell cancer”.

Why patient education is important in oncology

We talked to Dr Bettina Ryll of Melanoma Patient Network Europe about changes in melanoma treatment and how the added complexity of new treatments has changed how patients need to be informed.

Dr Ryll believes that educating and communicating these changes in therapy to patients is a challenge. She also points out that patients who are educated and have good knowledge of their disease and treatment, fare better than patients who do not have this knowledge.

Therefore, the Melanoma Patient Network Europe has a heavy focus on education for patients in order to improve outcome. Dr Ryll also highlights the importance of working together with oncologists to achieve this.

Custirsen shows no survival benefits in metastatic prostate cancer

In his press brief, Karim Fizazi of the Gustave Roussy Institute presented the final results from the Phase III AFFINITY trial.

The trial looked at the use of custirsen together with chemotherapy for second-line in patients with metastatic prostate cancer who are resistant to hormonal therapy and also first-line chemotherapy. The trial was a randomized study and patients were treated with either cabazitaxel plus prednisone plus custirsen or cabazitaxel and prednisone alone. Patients continued treatment until cancer progression and the primary endpoint was survival.

In his press brief Dr Fizazi explains that the goal of combining chemotherapy and custirsen was to achieve better results than seen with chemotherapy alone.

He further explains that the addition of custirsen to second-line chemotherapy with cabazitaxel did not significantly improve OS. Further, there was no new safety signal and no imbalance of active drugs beyond progression.

So there are two possible questions – either clusterin is not a relevant target in this disease, or the target was not inhibited enough with the compound we have at the moment.

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