Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #3

2018: A Record Year for Global Cancer Treatment Approvals

The publication of an annual review of global oncology approvals, by Bruno Pagliara, Principal at On-Kòs Pharma, has become a highly appreciated and comprehensive analysis of the activity and the vitality of the field.

This year article “The productivity of oncology development continues” published in the January 2019 issue of MedNous (full report on www.mednous.com) shows that new drug and new indication first approvals were at a record high again and sends a clear sign that innovation and productivity in oncology development continues to improve.

Bruno Pagliara indicates that 2018 was again a year of accelerated innovation and highlights four major topics underlying his statement.

“First, 20 new oncology drugs received a first approval in at least one of four geographical regions namely the European Union, the United States, Japan and China. In these regions there were also 42 first approvals for additional indications for drugs already on the market. Altogether, the new drugs and new indication approvals reached a record high of 62 versus an already previous high of 57 in 2017”. Among the drugs approved with entirely new modes of action, three were developed for rare cancers: neuroendocrine tumours, hairy cell leukemia and blastic plasmacytoid dendritic cell neoplasm.

The US FDA has also approved:

–  a first drug of a new class known as IDH1 (isocitrate dehydrogenase-1) inhibitors, for the treatment of acute leukemia,

– a second drug directed against multiple tumours based on a common tumour molecular characteristic rather than its location in the human body.

“Second, for the first time China has become a major player in the oncology field with six chemical or biological entities approved by the Chinese regulator, thus meeting standards comparable to those in effect in other major countries”. It is of more than passing interest to note than Hutchinson China Meditech (Chi-Med)’s VEGFR 1,2 and 3 inhibitor fruquitinib, the first China-made cancer drug, was approved in China last September for the treatment of metastatic colorectal cancer, but also to recognize BeiGene’s BTK inhibitor zanubrutinib getting US FDA breakthrough designation on January 14, 2019.  China’s recent work on streamlining its drug evaluation process and on adopting new policies for intellectual property protection are strong factors encouraging innovation. One of the policies the Chinese authorities have implemented in 2018, is a priority review pathway which consists in expediting and accelerating the development and approval of drugs with significant public health benefit. “Eleven oncology drugs from non-Chinese companies have already been declared eligible for this review pathway” according to Pagliara

Third, the immuno-oncology approach is still flourishing. Within the four aboved-mentioned geographical region, nine checkpoint inhibitors, two chimeric antigen (CAR) T cell therapies and one oncolytic virus therapy have already received marketing approval. In 2018, two new combinations therapies and nine new indications for approved drugs were granted. “Altogether the total number of approvals of checkpoint inhibitors sums up to 53 in 16 different indications” writes Pagliara.

Fourth, the successes of many companies should not offset the increasing number of late-stage clinical trials failures. This was true with checkpoint inhibitors, as single agents as well as in combination therapies, with antibodies, with antibody drug conjugates (ADC), with kinase inhibitors and with an IDO1 (Indoleamine-pyrrole 2,3 dioxygenase-1) inhibitor alone or in combination with a well-established checkpoint inhibitor.

Bruno Pagliara concludes his article with a review of the overall portfolio of oncology drugs in development and estimates that 2019 could well be as successful as 2018.

His proprietary database shows that, as of 31 December 2018, there are:

• 11 drugs under regulatory review
• 144 compounds in late stage development
• 26 single arm Phase 2 studies suitable for registration
• 293 drugs in Phase 2
• 342 new drugs entering Phase 1 (there were 254 in 2017)
• 927 drugs in Phase 1

“With the arsenal of existing efficacious cancer drugs and the impressive number of ongoing trials in the field, it will soon be impossible to find patients eligible to enter a clinical trial with a new cancer drug candidate except if you go to China” recently said an R&D Executive.

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  Btobioinnovation has no obligation to update its opinions or the information in this document.