A new cancer treatment recently approved in Canada promises to cut treatment time down to just minutes, but experts have differing opinions on whether it's what's best for patients.
One fears that it will unnecessarily use a higher dose of an existing drug and is likely to be pricier than the current method of administrating it intravenously.
By contrast, another oncologist says it is a welcome development that can drastically reduce the time for cancer treatment.
Health Canada approved the sale of Tecentriq SC last month, a prescription medication that treats patients with lung cancer, liver cancer and breast cancer in a new subcutaneous formulation of the already approved drug atezolizumab.
Atezolizumab is currently used in intravenous form as Tecentriq IV to treat various tumours. The new subcutaneous type of cancer immunotherapy treatment injects the drug under the skin instead of intravenously into the veins.
Mississauga, Ont.-based pharmaceutical company Roche Canada said in a news release last week that the Tecentriq subcutaneous injection helps to strengthen the immune system's ability to fight cancerous cells. The company told CTVNews.ca that it's the first cancer immunotherapy subcutaneous injection for multiple cancer types in Canada.
This treatment has been approved in more than 30 countries. Switzerland-based pharmaceutical giant F. Hoffmann-La Roche Ltd. is Roche Canada's parent company.
In addition to boosting the immune system, another potential benefit to patients is the flexibility this new treatment offers.
Roche Canada said the Tecentriq subcutaneous injection must be administered by a qualified health-care professional, but this could be done outside of a hospital, in another facility or even at a patient's home.
Sharlene Gill, president of the Canadian Association of Medical Oncologists, said in a video interview with CTVNews.ca the subcutaneous formulation would reduce the time to treat patients who typically receive immunotherapy for a long period.
Administering subcutaneous injection under the skin could be done faster, such as in about 15 minutes compared to about an hour through IV, she explained.
"I'm not sure I would call it a game-changer, but I would say that this really matters to people in terms of: it may not be a new medicine, but it's a better way of being able to deliver a highly effective medicine," said Gill, who is also a professor of medicine at the division of medical oncology at the University of British Columbia in Vancouver.
"Where it can be done and how quickly it can be done are probably the two big benefits ... For patients living with cancer, time is their most precious commodity."
It could also free up the system to deliver treatment to more patients in hospital and provide more equitable access to cancer care for patients who may not live in a big city or near a chemotherapy unit, she added.
While Gill spoke about the benefits to patients, Bishal Gyawali, a medical oncologist and oncology professor at Queen's University in Kingston, Ont., said he has some concerns.
He said he doesn't believe Tecentriq SC is drastically different from what is already available since it uses the same drug, atezolizumab, which currently exists in intravenous form. Gyawali is co-founder of a movement made up of medical professionals and patient advocates called Common Sense Oncology, which aims to promote a more patient-centred approach to oncology.
For certain cancers, other immunotherapy drugs have better quality evidence and are preferred over atezolizumab, he added.
"This (subcutaneous treatment) does not change outcomes, because it's just a matter of convenience – intravenous injection versus subcutaneous injection," Gyawali said in a video interview with CTVNews.ca. "In terms of efficacy, it's the same thing as an intravenous drug."
Gyawali said he feels it's not a big burden to take atezolizumab intravenously, as the drug is given once every four weeks. He said the evidence suggests an intravenous injection could even be given every eight weeks with the same effect.
Based on the way atezolizumab has been tested in one clinical trial, Gyawali says Tecentriq SC will be sold and used at a higher dose of 1,875 milligrams. That's equivalent to the IV dose of 1,200 mg in terms of achieving drug concentration in the blood, Gyawali said. However, he believes the 1,200 mg dose every three weeks is more than what is needed for "optimal efficacy."
The study concluded that intravenous and subcutaneous treatments are equally effective. Its results were published in the Annals of Oncology in August 2023. F. Hoffmann-La Roche Ltd., the parent company of Roche Canada, funded the trial.
Gyawali said it's a "missed opportunity" as the trial tested the higher dose despite evidence that a lower dose can be equally effective.
He said that the IV dose is already higher than what is needed for patients.
"There is no doubt about it but the industry is testing or recommending a higher dose than what is needed and not testing lower dose simply because with higher dose they can make more money," Gyawali said.
What's more, he said, he expects the new subcutaneous injection will cost "substantially more" than the intravenous version in part because he thinks it will be marketed as offering convenience.
"How much more are we willing to pay for a subcutaneous injection versus the same drug in the intravenous form that patients can get once every month?" he said. "What is the price of comfort, so to speak?"
In addition, he said he fears a potentially higher dosage of atezolizumab or any immunotherapy, regardless of formulation, could lead to more side effects, drug wastage and higher costs. He described a problem with what he said were unnecessarily higher doses involving other immunotherapy drugs such as pembrolizumab and nivolumab, as well.
The headquarters of pharmaceutical giant Roche is shown in Basel, Switzerland on Feb. 17, 2015. (Sebastien Bozon / AFP via Getty Images)
CTVNews.ca asked Roche Canada about Gyawali's accusations the company was mainly motivated by profit over patients' best interests in testing higher doses that the oncologist believes are unnecessary for the treatment.
"Roche does not base medication dosage on revenue or profits," Laura Pagnotta, spokesperson for Roche Canada, said in an email to CTVnews.ca. "Our clinical programs are developed with healthcare professionals specializing in the disease areas where the therapy will be used to treat patients. We carefully balance the efficacy of the treatment with the potential for side effects - patient tolerability is paramount in our studies."
She cited a March 2024 study, which was funded by her company, published in ESMO Open, the European Society for Medical Oncology's online-only, peer-reviewed open access journal. "The trial demonstrated patient preference for the SC formulation due to its reduction in clinic time and more comfortable route of administration. Additionally, no new safety findings were reported or concerns in switching between formulations," she said.
"Roche remains committed to innovation in oncology, to providing effective, more convenient treatment options for patients and ones that save the healthcare system time and resources. Tecentriq SC is our most recent example of this commitment," she added.
Regarding concerns about potential side effects from higher doses, Pagnotta said the clinical study published in the Annals of Oncology found no serious safety concerns.
"The safety profile of the Tecentriq SC formulation is consistent with that of Tecentriq IV and the rate of adverse events (side effects) was similar in clinical trials," Pagnotta said. "No infusion-related reactions occurred in the study of Tecentriq SC and injection-site reactions were mild in nature, had no impact on administration, and were mostly resolved without additional treatment."
Calling it "an important first step," Pagnotta said the company can now have conversations with the pan-Canadian Pharmaceutical Alliance and the federal, provincial and territorial agencies to discuss "the price, the value of the innovation, and the data to support both."
"We have a robust package to submit for review and look forward to the discussion and to bringing this treatment to patients as quickly as possible," she wrote. "With a treatment like Tecentriq subcutaneous, we hope to not only ease the burden of treatment for patients, but also save some of the healthcare system costs associated with more labour-intensive and time-intensive treatments and formulations so that those resources can be diverted back into overall cancer study, prevention, and disease management across the system."
In a statement provided May 2, a spokesperson for Health Canada said it authorized the sale of Tecentriq SC after evaluating the quality, safety and efficacy data, including from clinical trials designed to identify the "maximal tolerated dose," submitted by the drug submission sponsor or manufacturer, and it didn't receive information to support a lower dosing regimen for the treatment.
"Health Canada thoroughly evaluated these studies to determine their validity and found that they provided sufficient evidence to demonstrate that the benefits of using Tecentriq at the proposed dose outweighed the identified risks," André Gagnon, spokesperson with Health Canada and the Public Health Agency of Canada, said in an email to CTVNews.ca.
If new guidelines are created in the future, Gagnon said there may be a "shift in the development of oncology drugs away from a focus on maximal tolerated dose to lowest dose with maximal benefit."
"In the meantime, Health Canada will continue to use its post-market surveillance program to monitor safety issues as they arise during real-world use of oncology drugs and have the power to remove any drug from the market if significant safety concerns are identified," he added. "At this time, Health Canada has not identified new safety issues associated with the use of Tecentriq."
While the new treatment reduces the complexity of delivering the drugs, Gill said it still has to be done by qualified professionals, and patients have to be monitored for side effects.
"I think these kinds of developments make incremental improvements in patients' experience on their cancer journey and how they're experiencing cancer," Gill said.
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