Week's news analysis

ESMO 2020: virtual but wealthy

By The Editor - 30 september 2020

The annual meeting of the European Society of Medical Oncology (ESMO) took place virtually this year, due to the Covid-19 pandemic. New treatment options were presented, new results were unveiled that could accelerate future adoption of medicines.

- What consequences of the Covid-19 pandemic?

Several studies underlined the consequences of the Covid-19 outbreak on cancer treatments in terms of delays and even cancellations. The threat of delayed diagnoses also loomed. "Covid-19 has had a major impact on the organisation of patient care, on the wellbeing of caregivers and clinical trial activities. There is a risk that the diagnosis of new cancer cases will be delayed and that more patients will be diagnosed at a later stage of their disease," explained Dr Guy Jerusalem, from the Centre Hospitalier Universitaire Sart Tilman in Belgium.

Oncology centres in 18 countries were asked what type of activity had been most impacted: 60.9 % reported that clinical activity was reduced at the peak of the pandemic, while 64.2 % cited under-treatment and 37 % expected to see significant reductions in clinical trials this year. Moreover, 46 % of centres reported that more than one in 10 patients missed at least one cycle of treatment.

In details, the cancer treatments most likely to have been cancelled or delayed were surgery (in 44.1 % of centres), chemotherapy (25.7 %) and radiotherapy (13.7 %), while an earlier end to palliative care was observed in 32.1 % of centres.

- Are European countries equal to have access to cancer medicines?

Access to cancer medicines is highly unequal across Europe both for new drugs in development and for currently approved drugs due to huge disparities in healthcare spending by different countries, according to studies released during Esmo 2020.

Wealthier European countries spent ten times as much as poorer countries per inhabitant on cancer medicines in 2018. The top spenders on cancer medicines were Austria, Germany and Switzerland (90 to 108 Euros per capita) while the lowest spenders were the Czech Republic, Latvia and Poland (13 to 16 Euros). The largest differences in spending between countries were observed for immuno-oncology drugs.

Countries in Western Europe also ran a higher number of clinical trials for novel cancer treatments than countries in Eastern and Central Europe. "Having access to clinical trials confers several benefits to cancer patients. It means they can potentially access novel therapies earlier during the trial phase rather than having to wait for licensing and reimbursement," explained experts.

Analysing the number of trials in 34 European countries between 2009 and 2019 revealed huge differences. Albania had the lowest number of active clinical trials for cancer (0.14 clinical trials per 100 000 population) while Belgium had the highest number (11.06 per 100 000).

Further results showed that the total number of oncology clinical trials performed in European countries increased by 33 % between 2010 and 2018, with a much greater increase in early phase trials (61 % increase in phase I-II trials) than late-phase trials (7 % increase in phase II-III trials).

- Trials to follow (selected by Pharmanetwork Editor)

Merck and Eisai's Keytruda-Lenvima combo showed promise in several tough-to-treat cancer types.In a basket study called Leap-005, the combo triggered a response in 29 % of patients in previously treated triple-negative breast cancer, in 32.3 % of ovarian cancer patients who had tried three prior options and in 21.9 % of non-microsatellite instability-high colorectal cancer patients. Keytruda and Lenvima didn't do as well in third-line gastric cancer or second-line biliary tract cancer, recording a 9.7 % response rate in each group. Merck & Co. already has an approval for Keytruda in tandem with Lenvima in endometrial cancer.

In patients with pancreatic neuroendocrine tumors, Chi-Med's surufatinib staved off disease progression for a median 10.9 months among Chinese, in a phase 3 trial, against the 3.7 months posted by the placebo group. The company hopes data from this pancreatic NET trial and a previously announced positive study in non-pancreatic NET, as well as global trials, can earn it an FDA approval to challenge Novartis' Afinitor and Pfizer's Sutent.

Sanofi and Regeneron Pharmaceuticals presented detailed results from a Phase III study of Libtayo (cemiplimab) in patients with first-line locally advanced or metastatic non-small-cell lung cancer (NSCLC) who tested positive for PD-L1 in at least 50 % of tumour cells. In the overall study population, after a median follow-up of 13 months, Libtayo reduced the risk of death by 32 % compared to chemotherapy, while median OS in the two groups was 22.1 months and 14.3 months, respectively. Libtayo also reduced the risk of disease progression by 41 %.

In triple-negative breast cancer (TNBC) , Roche announced results from two Phase III studies of Tecentriq (atezolizumab), with one trial hitting its main goal, and the other failing.

The IMpassion031 study, which investigated Tecentriq in combination with chemotherapy (Bristol Myers Squibb's Abraxane (nab-paclitaxel) followed by doxorubicin and cyclophosphamide) for the treatment of people with early TNBC, regardless of PD-L1 expression, met its primary endpoint of pathological complete response (pCR). pCR in patients who received Tecentriq in combination with chemotherapy was 57.6 %, which was significantly higher than 41.1 % seen in those given placebo plus chemotherapy. Meanwhile, in patients with PD-L1-positive tumours, pCR in the two groups was 68.8 % and 49.3 %, respectively.

Meanwhile, the IMpass131 study shows that Tecentriq in combination with paclitaxel failed to significantly improve progression-free survival (PFS) for the first-line treatment of patients with metastatic TNBC, in the PD-L1-positive population. Roche noted that the overall survival (OS) data showed a negative trend, although the drugmaker indicated that the study was not powered for this endpoint and the survival data "were immature" at time of analysis.

In patients with gastroesophageal cancers, findings from two Phase III studies demonstrated that first-line use of immunotherapies by Merck & Co. and Bristol Myers Squibb led to superior overall survival (OS) and progression-free survival (PFS). Merck's Keytruda and Bristol Myers Squibb's Opdivo (nivolumab) respectively cut the risk of death by 27 % and 29 % versus chemotherapy alone.

The KEYNOTE-590 trial tested first-line use of Keytruda plus chemotherapy, versus chemotherapy alone. After a median follow-up of 10.8 months, the median OS among patients who received Keytruda was 12.4 months, compared to 9.8 months for chemotherapy alone. The risk of disease progression or death was reduced by 35% in the Keytruda arm, where median PFS was 6.3 months, versus 5.8 months in the comparator group.

Meanwhile, results from the CheckMate -649 trial showed after a minimum follow-up of 12 months, the risk of death was reduced by 29 % in the Opdivo group, where median OS reached 14.4 months, compared with 11.1 months for chemotherapy alone. Opdivo was awarded accelerated approval in June for use in patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.

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