By Alan Sandler (Senior Vice President, Oncology Product Development) and Nancy Valente (Senior Vice President, Oncology Product Development)
Published 10 July 2019 (this article first appeared on gene.com)
When we each began our careers as oncologists in the early 1990s, cancer treatment was very different than it is today. For decades, newly approved cancer medicines — including new uses for existing ones — had been arriving at a pace of only one to two a year. With so few medicines, we generally treated patients with some standardised combination of surgery, chemotherapy and radiotherapy based on where the cancer originated. Cancer mortality was at an all-time high, and there were limited guidelines, support networks and educational resources for patients.
Yet there was a growing sense of optimism that we could make progress. We started seeing that promise fulfilled at first with improved chemotherapy agents. Then in 1997 and 1998, the U.S Food and Drug Administration (FDA) approved the first targeted antibody and the first personalised medicine for certain types of cancer. We feel proud that those medicines were pioneered by scientists at Roche/Genentech, but it’s also humbling to see how much progress the cancer community has made collectively in the past 20 years. Today, oncologists have a vast array of options — every year since 2010, the FDA has approved at least a dozen new medicines or new uses for existing ones. In turn, more patients are surviving longer and treatment has become more holistic, evolving to include specialists like reconstructive surgeons, psychiatrists, career counselors and access specialists.
These newer medicines have rewritten the rules for patients, families and healthcare professionals, who increasingly find it possible to manage certain cancers as chronic conditions rather than terminal illnesses. And these medicines are qualitatively different; in addition to chemotherapies, there are now more than 80 medicines that work either by interfering with some specific aspect of cancer biology or by activating the immune system against cancerous cells.
At Roche, we have the privilege to help guide new medicines from the lab to the clinic, and we’re excited to be part of a renewed era of cancer research where we can harness our understanding of cancer and combine it with real-world data and advanced analytics to accelerate the pace even further. As the complexity of cancer care increases, we are asking ourselves questions from every facet of patient care: which medicines can we develop to help the people who have the greatest need today? Which endpoints would give us the most information to help healthcare professionals make the best treatment decisions? Can we find new combinations of medicines, perhaps by working with other companies, that will improve outcomes? How can we design trials to get results faster while maintaining the necessary rigor? How do we advance not just the medicines themselves but the delivery of care? We evaluate questions like these based on the data we have available, what the science tells us and what will help patients with the most difficult-to-treat diseases.
Partnering to personalise
Many of the advancements we’ve seen represent the first stages of a personalised healthcare transformation that will dramatically change the practice of medicine in coming decades. So we’re doing what we can to move that process forward, by developing the infrastructure and using tools that accumulate and analyze large amounts of patient data and can help inform treatment decisions. Data security is crucial here, so we’re also enforcing strict protocols to keep those data secure. Personalised healthcare will not succeed unless people can contribute their data to the advancement of science with peace of mind.
We’ve already made encouraging progress in matching patients to treatments and identifying new combinations that span chemotherapy, multiple targeted medicines and immunotherapies. And we’re pushing the concept of personalised medicine to its limit with research into individualised cancer vaccines that use the unique combination of molecular tags in a person’s cancer to direct their immune system against it. Using insights gained from genomic profiling, we’re also uncovering commonalities like gene fusions and mutations that span diverse cancers, making it possible for a single medicine to treat many different tumor types no matter where they originated. As these tumour-agnostic therapies grow in number, oncologists can increasingly begin to think of cancers not by their site of origin, but by the characteristic mutations that make them vulnerable to particular treatments. This approach is especially important in rare cancers, including many found in children, where it may be difficult to enroll enough patients in a clinical trial to gather sufficient data on a single type of disease.
Advancing analysis and analytics
Our belief is that innovations like these will change what it means to be diagnosed with cancer. As they do, however, we’ll need to find ways to get transformative treatments to patients faster. One way we can do this is by using real-world data to populate the control arm of a trial, so we don’t need to enroll patients to receive the standard of care. This approach gives all participants access to the experimental therapy, and also helps accelerate enrollment, which may in turn lead to faster availability.
Our clinical trials also incorporate novel endpoints, which give us an earlier indication of whether a treatment is outperforming the standard of care or can help signal how long a person may benefit from a medicine. As cancer patients live longer after diagnosis, these new measures will be more appropriate and efficient than traditional endpoints that take longer to measure.
All of these developments convince us that we are living in an exceptional era with respect to advancements in cancer treatment — and that in some respects the progress has only just begun. But to keep moving forward, we can’t work in a silo. Our chief medical officer Sandra Horning once noted that we are "partners, investors, catalysts and disruptors” in the fight against cancer, and we must make it a point to keep this top of mind in our quest for better treatments for patients. How do we, along with the cancer community, deal with some of these big issues in how we deliver healthcare? How do we break down the silos separating people involved in healthcare? It’s comforting to know we’ve come a long way in even the last 20 years, but with what we have available to us now, we must do more so that the big solutions will come sooner.
At Roche, we are fortunate enough to have access to the best scientists; robust databases of real-world and genomic data; innovative partners; and resources to build a comprehensive portfolio that encompasses medicines, diagnostics and data. We believe this could be a model for the future of industry-led innovation and believe it will ultimately result in better outcomes for all people with serious diseases, including cancer. And no one can make meaningful progress against cancer alone. We intend to continue working with the cancer community to advance and shape patient care until every person who is diagnosed is a survivor.