The Aga Khan University Hospital, Nairobi (AKUH,N) has launched a first in Africa cancer drug clinical trial to investigate the effectiveness of a new treatment that blocks the activity of a gene mutation responsible for the cause of cancer in affected patients. AKUH,N is the only site selected in Africa for the testing of this new treatment.
The study follows the approval of a similar drug to treat lung cancer by the USA’s Food and Drug Administration (FDA) in 2021.
The gene in question is the KRAS gene, explains Prof Mansoor Saleh, the Director of the Aga Khan University’s Cancer Center and the Hospital’s Clinical Research Unit (CRU):
“The KRAS gene is what we call a housekeeping gene, present in all cells of the body and is responsible for growth and survival of normal cells. In normal conditions, the KRAS gene gets activated when parts of the human body grow and becomes functionally active. After that, KRAS goes into the in-active state. Sometimes, however, KRAS activation becomes uncontrolled resulting in uncontrolled growth, which then leads in some cases to cancer. In about 30% of cancer tumours, the KRAS gene is mutated and goes into uncontrolled activation state making it a cancer-causing gene or anoncogene. The KRAS G12C Oncogene is a mutated KRAS gene, which is reportedly responsible for the development of lung cancer, colon cancers and some other human cancers,” Prof Saleh explains.
Scientists have recently developed inhibitor molecules that block the activation of the KRAS G12C oncogene. This inhibitor molecule has the potential to block the cancer-causing property of KRAS G12C.
“The Cancer Center at the Aga Khan University Hospital recently embarked on a clinical trial to test the anti-tumor property of GDC 6036, an experimental treatment that blocks the activation of the KRAS G12C oncogene in human tumours. The pill developed by Roche Pharmaceuticals is intended to block the function of KRAS G12C and thereby stop the uncontrolled cell growth and division of the cancer in those patients,” added Prof Saleh.
A similar gene blocker recently received FDA approval specifically for use in patients with lung cancer who carry the KRAS G12C mutation. AKUH,N is the only site in Africa studying the effect of this gene blocker on tumours other than lung cancer that also share this KRAS G12C mutation.
“When detected early, surgery, conventional chemotherapies and radiation therapy can be successful and curative. However, when conventional therapy fails, the outcome is often bleak. This gene blocking therapy is the first such precision oncology treatment on a patient with metastatic colon cancer, whose tumour carries the KRAS G12C mutation,” added Prof Saleh.
The first patient in the African continent on this trial is a Ugandan national who is currently receiving this experimental therapy.
While commenting on the trial, AKUH,N’s CEO Rashid Khalani noted that it is in line with the hospital’s commitment to increase the participation of Africa in global cancer trials.
“As a University Hospital we have a mandate to contribute to the development of effective and relevant treatments. We are therefore very delighted to be participating in this trial that we believe is going to develop therapies that are relevant to the African population,” said Mr Khalani.
Cancer is the third leading cause of death in Kenya, with the World Health Organisation estimating that there are over 40,000 new cases and over 28,000 cancer-related deaths every year.
“To deal with the cancer menace, we must increase the research on the disease, invest more in public awareness and more importantly train more specialists to take care of the increasing number of cancer patients. That is why last year we launched a new fellowship in Medical Oncology, as part of our efforts to increase the number of cancer specialists in the region,” said Mr Khalani.
AKUH,N established its Clinical Research Unit in 2020 to spearhead clinical trials in the region and form the cornerstone of cancer research in East and Central Africa. This was informed by the need to develop treatments that are more effective in the African population since most of the drugs used for treatments are tested in western countries with limited participation of the African population.
“Research has found that there are genetic differences between the African population and the rest of the world. This means that we have to study novel treatments on our population for they may respond differently or have more or less toxicity than patients from the West. This is exactly the reason why we at Aga Khan University have made the conduct of clinical trials and the establishment of the clinical research unit our mandate,” explained Prof Saleh.
CRU is currently involved in several clinical trials. Previously it has completed clinical trials for Covid-19 vaccine and the use of Tocilizumub to treat critically ill Covid-19 patients.