Although the “war on cancer” was officially announced by President Nixon in 1970 and signed into law in 1971 through the National Cancer Act, this war has been ongoing since the Hippocratic era. What’s changed within the last 50 years, however, is the knowledge base that informs the therapeutic treatment paradigm.
Nonetheless, there are still skeptics, who look at new therapies as untested and likely to be ineffective. Dr. Vincent T. DeVita, professor of medicine at the Yale School of Medicine and former director of the National Cancer Insitute, wrote about this dynamic in “The Death of Cancer.”
"In 1963, there were only two well-accepted ways to treat cancer: radiation and surgery," he wrote.
In fact, according to Dr. DeVita, doctors who were using early forms of chemotherapy in the 1960’s, known as “chemotherapists,” were “reviled.” Now, roughly five decades later, chemotherapy in combination with surgery and radiation, is part of the standard-of-care, with immunotherapy rapidly becoming a standard part of treatment protocols.
NovoCure introduces non-invasive Tumor Treatment Fields for brain cancer
Long gone are the days of radical surgeries designed to remove cancers “en bloc,” such as Halsted’s radical mastectomy in which breast cancer was addressed by cutting off both breasts, lymph nodes in the nearby armpit, and all of the muscles covering the chest wall, as well as part of the shoulder bone if the surgeon saw fit.
Increasingly treatment of cancer has become personalized therapy, which combines various modalities and combination regimens, including therapies that are less invasive.
One example is a relatively new therapy known as Optune (Tumor Treatment Fields delivery system), a medical device that was approved in 2011 for second-line treatment of adults with gliobastoma (GBM).
Last year, Optune (in combination with temozolomide) received an indication from the FDA for first-line treatment of GBM based on the strength of phase 3 data showing significant improvements in progression-free survival and overall survival—strong enough data to justify stopping the trial early.
What are tumor treatment fields?
Tumor treatment fields (TTFields) are low-intensity, alternating electric fields that operate at intermediate frequencies, changing polarity hundreds of thousands of times a second. This therapy’s anti-cancer effect occurs as a result of disrupting electrically charged molecules that are essential to the mitotic process.
TTFields are continuously delivered to the patient through insulated transducer arrays placed directly on the skin in the region surrounding the tumor. Patients wear the device day and night during the treatment period.
Optune is intended to be used as a monotherapy for recurrent GBM, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In addition, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
Targeting additive efficacy as a therapeutic goal
"Our research shows that TTFields have an anti-mitotic effect in over 15 different solid tumor types in culture and in multiple in vivo tumor models," said NovoCure CEO Asaf Danziger in an interview.
"In vitro and in vivo studies combining TTFields with radiation or chemotherapy, in multiple tumor types, have demonstrated at least additive efficacy, or stronger efficacy than the effect of either treatment alone, and in some cases synergistic efficacy, or stronger efficacy than the sum of the effects of both treatments."
"We are supporting independent research into the optimal combinations of TTFields with radiation or pharmacological therapies to expand the population of patients who may benefit from TTFields."
Noninvasive means very few side effects
Given what researchers have learned about cancer, NovoCure’s therapy represents another way to potentially extend the lives of patients with aggressive glioblastoma, which has a five-year survival rate of 10% to 30%.
Plus, as Danziger pointed out, "Based on the research, there are no significant additive systemic toxicity from Tumor Treating Fields therapy when using Optune.
"Patients generally maintain stable quality-of-life, cognitive function and activities of daily living."
Driving uptake of an unknown cancer therapy
Many oncologists are not familiar with Optune and have not factored it into their treatment protocol. Therefore, NovoCure has focused its communications and marketing efforts on the roughly 200 neuro-oncologists in major academic centers in the U.S.
"The new indication for Optune has expanded our target prescriber base," said Danziger.
"Newly diagnosed GBM patients are primarily treated in non-academic, community practices where the radiation oncologist and medical oncologist, in addition to, or in place of, the neuro oncologist, can play a key role in the treatment decisions.
"As of December 31, 2015, we certified 244 centers in the United States and estimate that approximately one-third of these centers are community-based practices."
Sales, marketing and dealing with payers
For NovoCure, the new primary treatment indication for Optune has effectively increased their target treatment population in the U.S., which includes 5,400 recurrent patients, in addition to 9,300 newly diagnosed patients.
"Our sales and marketing teams are now able to communicate clear superiority data versus the existing standard-of-care. We have proof of extended overall and progression-free survivals in GBM. This is in contrast to our previous, recurrent GBM label that specified equivalence to standard chemotherapies," Danziger said.
On the payer side, NovoCure has secured coverage from two major US commercial payers, including Tricare and Medicare Advantage, for 99% of all patients under treatment with Optune as of Q3 2015, according to Danziger.
And in the face of payers who don’t want to pay, Novocure is actively appealing denials in the Medicare fee-for-service program which represents approximately 25% of the US patient population.
More therapies means more time to find a cure
In “The Death of Cancer,” DeVita described the goals of treating a hard-to-beat cancer. Essentially, the goal is to use available therapies to keep the patient alive until a new therapy comes along that can keep them alive even longer, or possibly be curative.
Danziger, who has a similar view, is an enthusiastic supporter of Cancer Moonshot 2020, and an avid adherent to the idea that personalized combination therapy is the key to improving survival rates.
"Physicians have typically treated patients with solid tumors using one or a combination of three principal treatment modalities—surgery, radiation and pharmacological therapies," he explained.
"Despite meaningful advancements in each of these modalities, a significant unmet need to improve survival and quality of life remains. We believe we will establish TTFields as a new treatment modality for a variety of solid tumors that increases survival without significantly increasing side effects when used in combination with other cancer treatment modalities."