CLINICAL TRIAL OF SELPERCATINIB SHOWS STRONG
RESPONSE FOR PATIENTS WITH NON-SMALL CELL LUNG
Singapore, 28 September 2020 – An international team of researchers has found
that selpercatinib, a drug that precisely targets cancers driven by mutations or
alterations in the gene RET, was effective at shrinking tumours in patients with nonsmall cell lung cancer (NSCLC), with a majority of patients living for more than a year
without disease progression. Activity was also observed in thyroid cancer, and the
findings were recently published in two back to back papers in the high-impact factor
journal, New England Journal of Medicine.
Non-small-cell lung cancer accounts for more than 80 percent of all lung cancers.
Cases of lung cancer in people who have never smoked are usually non-small-cell
lung cancer. The disease affects more women than men. Standard treatment for nonsmall-cell lung cancer is a combination of surgery, chemotherapy and radiotherapy,
with no targeted therapy option. Patients with advanced non-small-cell lung cancer
have poor prognosis with median overall survival rate of 12 months (Toh et al. Annals
academy Singapore 2017)
Selpercatinib was effective both in patients with no prior treatment with anti-cancer
drugs and in those who had disease progression after treatment with other drug
therapy. Results of the Phase 1-2 trial formed the basis of approval of selpercatinib in
May 2020 by the US FDA for a) adults with metastatic RET-driven non-small cell lung
cancer, b) adults and children 12 and older, with advanced or metastatic RET-mutated
medullary thyroid cancer who require systemic therapy, and c) patients 12 and older
with advanced or metastatic RET-fusion positive thyroid cancer resistant to radioactive
iodine who require systemic therapy. Selpercatinib is the first approved drug of its kind
that specifically targets cancers driven by mutations or alterations in the gene RET.
Patients with RET-associated cancers are typically treated with drugs that target RET
and multiple other enzymes commonly found in many different types of cancer.
However, the multi-kinase inhibitors currently approved for treatment have side effects
that limit their use in patients with RET-driven cancers. The most common side effects
with selpercatinib were high blood pressure, increased liver enzyme levels, decrease
in sodium levels and low white blood cell count, all of which were manageable. Only
12 out of 531 patients on the trial had to stop because of side effects.
Clinical Associate Professor Daniel Tan, Senior Consultant, Medical Oncology,
Deputy Head of the Division of Clinical Trials and Epidemiological Sciences, National
Cancer Centre Singapore and co-first author of the study said, “The trial showed the
targeted therapy to have good efficacy, strong, sustained response rates and fewer
side effects. It has also demonstrated the importance of molecular profiling, and
National Cancer Centre Singapore has implemented routine testing of the gene RET
for all lung cancer patients, to enable this group of patients to benefit from the targeted
In the trial, 64 percent of previously treated patients achieved objective response and
63 percent continued to respond after 1 year. 85 percent of patients who had not
previously received treatment, achieved objective response, with the median duration
of response being 17.5 months.
Professor William Hwang, Medical Director, National Cancer Centre Singapore said,
“This targeted therapy will provide patients with non-small-cell lung cancer with
significantly improved health outcomes. The National Cancer Centre of Singapore is pleased
to have participated in this trial to find precise oncology treatment options for patients.
This underscores the important role the Experimental Cancer Therapeutic Unit plays
in running impactful early phase clinical trials that can define new standards of care.”
The trial involved the participation from 65 leading cancer centers around the world
from 12 countries including USA, Canada, France, Switzerland, Germany, Spain,
Australia and Singapore. The trial was supported by Loxo Oncology, a wholly owned
subsidiary of Eli Lilly and Company.
In Singapore, the trial was led by the Experimental Cancer Therapeutics Unit (ECRU),
at the National Cancer Centre Singapore, which supports early phase clinical trials
from Phase 0 to 2 trials. This inter-disciplinary team is engaged with preclinical and
clinical development of new anti-cancer drugs for all solid tumours and lymphomas to
offer patients new therapeutic options, and has spearheaded the Precision Oncology
programme IMPACT (Individualised Molecular Profiling for Allocation to Clinical Trials)
at NCCS, where more than 1500 patients have been recruited to date.
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National Cancer Centre Singapore
Manager, Corporate Communications
Executive, Corporate Communications
About National Cancer Centre Singapore
National Cancer Centre Singapore (NCCS) provides a holistic and multi-disciplinary approach
to cancer treatment and patient care. We see close to 65 per cent of the public sector oncology
cases, and they are benefiting from the sub-specialisation of our clinical oncologists. To deliver
among the best in cancer treatment and care, our clinicians work closely with our scientists
who conduct robust cutting-edge clinical and translational research programmes which are
internationally recognised. NCCS will also launch its Proton Beam Therapy programme at its
new centre. NCCS strives to be a global leading cancer centre, and shares its expertise and
knowledge by offering training to local and overseas medical professionals. www.nccs.com.sg
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