Breast Cancer Awareness Month: A look at recent innovations in breast cancer
Thirty years ago this month, the American Cancer Society and the company that is now AstraZeneca partnered with the goal of increasing breast cancer screening by raising awareness for one month per year. Those early efforts yielded a great deal of awareness around breast cancer, while also providing a foundation for increased knowledge about what factors increase breast cancer risk, as well as the newest treatments, the latest innovations and mainstay approaches that still work. The net result: The death rate from breast cancer has decreased 34% since 1990.
Despite all of the money raised, diagnostic intervention and hard work in research labs worldwide, breast cancer is still the leading cause of cancer-related death among women. This year, approximately 1.67 million women will be diagnosed with breast cancer, and roughly half a million women will die from it. In the U.S. only, this year, there will be a total of roughly 232,000 breast cancer diagnoses and 40,000 deaths.
The unmet medical need around breast cancer is as urgent as ever, because the needs of women with metastatic breast cancer are ongoing. Even given targeted treatments and surgery, women with metastatic breast cancer who become cancer-free will have a recurrence within 18 months. The question then becomes which new treatment can they turn to now that other approaches are no longer working.
New targets, new drugs
Since the introduction of Roche’s Herceptin (trastuzumab) in 1998, it has become a backbone treatment for many treatment regimens for women with HER2-positive breast cancer, a particularly aggressive form of breast cancer that represents 20% of cases. Herceptin ushered in an era in which molecular targeting went beyond estrogen receptors, and now there are numerous biomarkers that can be used to tailor individual treatment regimens in order to increase progression-free survival (PFS) and overall survival (OS).
Within the last 18 months, BioPharma Dive has reported on several emerging, recently approved, or expanded-indication therapies. Here’s a brief review of four stories, with a current update:
- In July 2014, Puma’s shares were up 300% on news that neratinib, a tyrosine kinase inhibitor for treatment of early-stage HER2-positive breast cancer increased disease-free survival by 33%, compared with placebo. These women had already undergone surgery and treatment with Hreceptin. However, in November, Puma reported that a phase II study comparing neratinib and paclitaxel versus neratinib and Herceptin had failed to meet its primary endpoint. Overall, PFS for women with metastatic or locally recurrent disease was 16.6 months, versus 16.7 months for the control group. Unfortunately, Puma was unable to replicate the results from the earlier trial.
- In August 2014, Pfizer filed for approval for palbociclib for treatment of women with ER-positive, HER2-positive cancer. The NDA was based on phase 2 data showing that median PFS in women treated with palbociclib and the aromatase inhibitor letrazole was 20.2 months, compared with 10.2 months for women treated with letrazole alone. The results were statistically significant. The FDA approved palbociclib, which is marketed under the name Ibrance, in February of this year. Ibrance is priced at roughly $118,000 per year and is expected to achieve blockbuster status.
- In September, Roche reported astonishing results for Perjeta (pertuzumab), which was originally approved in 2012 for treatment of patients with metastatic HER2-positive breast cancer and in 2013 for neo-adjuvant treatment of early-stage breast cancer patients. Based on the results, women in the trial had an almost 16-month increase in survival compared with the standard of care. This was hailed as the longest extension to survival ever seen in a clinical trial. All told, patients had a 32% decreased risk of dying. In addition, there was a very low level of cardiotoxicites, as well as a relatively benign overall side-effect profile demonstrated in the trial. Perjeta is already a blockbuster drug, and analysts expect sas to exceed $3.1 billion by 2018.
- Earlier this month, Lilly announced that its breast cancer therapy, abemaciclib, a CDK4/6 inhibitor had been given Breakthrough Therapy Designation for treatment of women with metastatic, hormone-receptor positive breast cancer. The FDA’s decision to give abeciclimib priority review was based on phase 1 results in which women who had already received a median of seven treatments responded to the drug, demonstrating both efficacy and safety.
Advances on the surgical front
Surgery continues to be the mainstay of breast cancer treatment, with a focus on removing all of the cancer, while also retaining as much tissue as possible. Towards that end, Navidea Biopharmaceutical’s Lymphoseek has played a significant role since approval in late 2013 for intraoperative lymphatic mapping during breast cancer surgery.
As the first approved technology in the last 30 years for use in sentinel lymph node biopsy (SNLB) surgery in breast cancer—and the first FDA-approved receptor-targeted mapping agent—Lymphoseek has improved surgical outcomes, while also improving the patient experience—a factor that cannot be overlooked.
"There has been great innovation in treating breast cancer, and with the emergence of immunodiagnostic and immunotherapeutic technologies, we are truly working toward the goal of precision medicine," said Dr. Michael Tomblyn, Chief Medical Officer of Navidea Biopharma in an interview.
"But there continues to be unmet need which requires not only maximizing clinical outcomes but improving the patient experience, including levels of invasiveness and pain. Providing surgeons and their patients with innovative choices that may improve standard of care beginning with diagnoses and surgery all the way through to guiding treatment is becoming a reality in cancer care."