Oncology

Oncology

Cancer is one of the most significant global health challenges today.

Research on global cancer burden shows more than 14 million new cancer cases were diagnosed in 2012,1 a number that is expected to grow to more than 20 million by 2030.2 In the United States alone, 1.7 million new cancer cases are expected to be diagnosed in 2018.3

Remarkable progress has been made in the fight against this disease. Five-year survival is increasing for many types of cancer, in large part due to early detection and better treatments. Current research holds enormous promise to fight the growing burden.

We are proud to be a part of the great progress being made in this fight. We have a long history of bringing forward innovative medicines in oncology, beginning with the approval of our first oncology medicine by the U.S. Food and Drug Administration (FDA) in 1986.4 Building on this foundation, our company has continued to invest in promising science and has developed a portfolio of medicines to treat cancer and cancer treatment-related conditions. These medicines span therapy types and patient needs, showcasing the depth and breadth of our commitment to cancer.

An anchor of that commitment is KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy. KEYTRUDA is a type of immunotherapy that harnesses the body’s immune system to help fight cancer. With the largest immuno-oncology clinical development program in the industry, we are exploring how KEYTRUDA can potentially help the greatest number of cancer patients globally.

We are committed to working with stakeholders to support accessibility to our cancer medicines through various initiatives, programs, and contributions. Many of these efforts are described below.

Our Legacy in Cancer Care

Timeline

Our first oncology product, INTRON A® (Interferon alfa-2b), is approved by the FDA. In 1986, it is the only treatment for hairy cell leukemia, a rare cancer that affects about 2,000–3,000 Americans at the time.5

Our expanding research portfolio and broad interest in cancer leads to actions to protect employees from cancer-causing risk factors. The establishment of a link between tobacco smoking and cancer leads us to change workplace policies to promote healthy living globally.6 In 1989, the company becomes one of the first corporations to establish a smoke-free workplace, encouraging employees to live healthier lives.

Our oncology portfolio continues to grow as we pursue cutting-edge cancer research. Our second oncology product, TICE® BCG (Bacillus Calmette-Guerin), is approved by the FDA for the treatment of carcinoma of the bladder—more than 50,000 new cases are diagnosed annually in the United States at the time of approval.7

Furthermore, in collaboration with the National Cancer Institute, we co-fund the creation of the Chemistry-Biology Center at Harvard University, which aims to screen and develop cancer drug candidates much more quickly in order to address the need for expedited discovery of cancer therapies.

At the turn of the century, chemotherapy is the standard of care for most cancer patients. TEMODAR® (temozolomide), our first chemotherapy, receives FDA approval in 1999 to treat certain types of brain tumors.

While chemotherapy is most effective on cancer cells, it also kills some healthy cells that are actively replicating. For patients being treated with chemotherapy, side effects often stem from the death of these healthy cells. In 2003, EMEND® (aprepitant), our fourth oncology product, is approved by the FDA to address nausea and vomiting caused by chemotherapy.

As we continue to learn more about how and why cancer develops, we begin to understand the ways to detect cancer earlier and prevent it altogether. In 2006, our first vaccine to prevent cancer, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], is approved by the FDA for the prevention of cervical cancer. This same year, we also receive FDA approval for ZOLINZA® (Vorinostat), which treats a certain type of lymphoma.

Through better understanding the biology of cancer cells, we learn how to use biological signals to control cancer cell growth. This type of therapy, called immunotherapy, harnesses the immune system to help identify and fight cancer cells. In 2013, we announce that our first immunotherapy, KEYTRUDA, receives Breakthrough Therapy Designation by the FDA for previously treated, advanced melanoma, indicating evidence of significant improvements over existing treatment options for serious or life-threatening diseases.8

KEYTRUDA is the first anti-PD-1 therapy in its class to be approved in the United States. In 2014, KEYTRUDA is approved for treating unresectable or metastatic melanoma with disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Just one year later, it is approved for treating patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 and who have disease progression on or after platinum-containing chemotherapy.

KEYTRUDA continues to reach regulatory milestones and expand to new indications. In 2017, it is approved for ten indications across many cancers. In May 2017:

  1. KEYTRUDA became the first cancer therapy approved by the FDA for use based on a biomarker, regardless of tumor type. This was a first-of-its-kind indication: the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  2. Additionally, KEYTRUDA was approved by the FDA in combination with pemetrexed (ALIMTA®) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, regardless of PD-L1 expression

“New medicines like KEYTRUDA are central to [our] mission to save and improve lives. Providing early access to promising investigational medicines helps us join with the scientific and medical communities in seeking additional ways to extend compassion, and potentially to extend or save lives.”

Dr. Scot Ebbinghaus
Vice President, Clinical Research, GCD – Oncology Melanoma

Access to Health Guiding Principles

Improving access to cancer care is our strategic priority.

To guide our efforts, we follow our company-wide Access to Health Statement of Guiding Principles, which articulate our approach and aspirations in the areas of Research and Development, Manufacturing and Supply, Registration, Commercialization, and Community Investment. We are working with governments and other stakeholders to help patients gain access to the oncology medicines that they need and to invest in health systems to expand the provision of quality cancer care.

Research and Development

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. Today, our portfolio includes oncology medicines that treat different cancers and conditions related to cancer treatment. Currently, we’re focusing our development program on our most recently approved oncology product, KEYTRUDA.

Clinical Research Program
In an effort to help as many people as possible, our company has created the largest immuno-oncology clinical development program in the industry. We are studying KEYTRUDA, our first anti-PD-1 therapy, in hundreds of clinical trials across 30 tumor types9 as both a single agent and in combination with other cancer medicines. With approximately 90,000 patients9 expected to participate in these clinical trials, we are aiming to help as many patients with cancer as possible. We also have more than 20 novel mechanisms9 being explored in our pipeline, in the clinic or close to entering the clinic, for monotherapy or combination with KEYTRUDA.

Combination Therapies
While single cancer therapies have proven to be effective in many patients, in some cases, combination therapies have delivered better clinical outcomes than stand-alone medicines.10 This scientific progress has the potential to improve patients’ survival and quality of life. It is because of this promise that we are also exploring combining KEYTRUDA with other cancer treatments in more than 400 clinical trials9 globally.

Deep Dive—Expanded Access Program (2014)

We are committed to bringing innovation to patients facing life-threatening conditions as quickly and equitably as possible. Our first priority with new medicines is to enroll patients in clinical trials to expedite regulatory approval, which enables access for the greatest number of patients. However, we recognize that there is often a time lag between providing evidence that a drug is effective and gaining regulatory approval.

The Expanded Access Program provided KEYTRUDA to more than 5,800 melanoma patients in 38 countries before it was approved. It helped patients of all ages—from 14 to 94. Thanks to regulatory approval, patients now have broader access to KEYTRUDA through the traditional healthcare systems.

“I was truly honored and humbled to be part of the KEYTRUDA early access team. In fact, it’s the highlight of my career. [Our] colleagues worldwide were driven to do what we do best—work to bring innovative science to help patients be well.”

Chet Bhatt
Executive Director, Global Medical Affairs

Registration

Once evidence has been collected regarding the safety and efficacy of a compound, it must be approved by the relevant regulatory agency before it can be prescribed and administered in a region or country. To prevent delayed access between products being deemed clinically beneficial and being approved, we have focused on expediting filings for regulatory approvals across the globe. This ensures that the greatest number of patients in need have access to our products as soon as safely possible. Reflecting our commitment to registration, KEYTRUDA is currently approved in 86 countries9 around the world.

Commercialization

After our products are approved by the local regulatory bodies, our next priority is to expedite reimbursement to support patients in getting access to care that they need as quickly as possible. In countries where reimbursement is delayed or not available, we undertake different approaches to improve patient access.

We acknowledge that costs for cancer care, including hospitalizations, management of complications, medicines, and other financial burdens, can be inhibitory to patients. Thus, we provide programs and initiatives to reduce these access barriers for patients. We support Patient Access Programs to enable patient access to our medicines by reducing patient inability to pay for cancer treatment. We have launched many of these programs across many geographies:

In the United States, our Patient Access Program supports patients who do not have insurance. Patients whose insurance does not cover KEYTRUDA may be eligible for free product, including product replacement, if they meet certain financial and medical criteria.

In other regions where there is limited or no reimbursement for KEYTRUDA, we have structured various Patient Access Programs and continue to explore initiatives which enable greater access to our products. These types of initiatives are currently active across Asia Pacific and the Middle East.

Deep Dive—U.S. Patient Support Program

Our company’s Patient Support Program in the U.S. provides free reimbursement support services to help answer questions related to insurance coverage and reimbursement. Learn more.

Lastly, the time lag between regulatory approval of a product and reimbursement of that product in a given country can present access challenges for patients in need. We are working to ensure timely reimbursement authorizations to ensure patients are able to access our products as quickly as possible. To that end, we have engaged with other industry partners to address these issues around timelines and reimbursement.

Deep Dive—Medicines Australia—Oncology Industry Taskforce

Due to increasing challenges in gaining timely, affordable and equitable patient access to new cancer medicines in Australia, several member companies of Medicines Australia came together to work in collaboration with key stakeholders to improve access to cancer medicines for the benefit of patients. Our company is one of 15 companies participating in the Oncology Industry Taskforce, which launched a report in May 2017 entitled, “A collaborative assessment of access to cancer medicines in Australia.” The report draws from Australian and international research and more than 30 interviews to provide practical and prioritized considerations for government and policymakers. This and other industry engagements will continue as we strive to improve access to our products.

Partnerships

We believe that many access challenges cannot be resolved in isolation. To enable broader access to cancer medicines and healthcare, we are undertaking a number of efforts in partnership with stakeholders, which target barriers to access from drug availability to reimbursement, while ensuring local infrastructure exists to treat patients across the pathway of care.

Our company’s Foundation established the Alliance to Advance Patient-Centered Cancer Care to increase timely access to patient-centered care and to reduce disparities in cancer care for vulnerable and underserved populations in the United States. The Foundation has committed $15 million over five years (2017–2021) to support the Alliance and its program partners in selected communities across the country.

Access Accelerated Initiative

Our company is a member of Access Accelerated, a first-of-its-kind, multi-stakeholder collaboration focused on improving non-communicable disease (NCD) care. Involving more than 20 pharmaceutical companies, the initiative works with partners such as the World Bank and the Union of International Cancer Control (UICC) to help overcome access barriers in low- and middle-income countries.

Deep Dive—City Cancer Challenge 2025 (C/Can 2025)

In partnership with UICC, Access Accelerated has launched C/Can 2025, a global, signature, cancer initiative to deliver robust cancer treatment solutions in cities in low- and middle-income countries with populations over 1 million. The initiative engages with cities in the design, planning and implementation of treatment solutions to improve the health of their citizens and reduce inequalities in access to quality cancer care.

The challenge addresses the need to ensure that functional, comprehensive cancer solutions are available for the majority of the world’s population. C/Can 2025 is piloting the model in three initial cities—Yangon, Myanmar; Cali, Colombia; Asunción, Paraguay. Upon proof of concept, the initiative will expand beyond these cities.

Our company has taken a leadership role in this initiative, spearheading a multi-stakeholder working group. Furthermore, by supporting C/Can 2025 and a holistic treatment solution, we and the rest of our industry partners have agreed to be prepared to negotiate on pricing if it is identified as a barrier to access in the gap analysis in pilot cities.

American Cancer Society Partnership

To address cancer care challenges in the U.S., our company’s Foundation provided a $1.58 million grant to the American Cancer Society (ACS) through a four-year partnership, which aims to expand ACS’s Patient Navigation Program in three communities where there are substantial disparities in cancer care.

The Patient Navigation Program provides guidance and support for cancer patients, their families and caregivers. More than 100 Patient Navigators are helping those affected by cancer in hospitals and cancer treatment centers nationwide. They help identify and reduce barriers to treatment, including challenges with language, transportation and health insurance.

1. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx.
2. American Cancer Society. Global Cancer Facts & Figures. 2nd Edition. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf.
3. American Cancer Society. Cancer Facts & Figures 2018. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf.
4. Food and Drug Administration. Clinical Review. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/bla/1997/ifnasch110697r.pdf.
5. https://www.washingtonpost.com/archive/politics/1986/06/05/cancer-drug-interferon-wins-approval-for-commercial-use/0046e95a-6cc8-402f-910a-09bad92eeb59/?utm_term=.87b606b08291.
6. Bode AM, Dong Z. Cancer Prevention Research—Then and Now. Nature reviews Cancer. 2009;9(7):508–516. doi:10.1038/nrc2646.
7. http://wayback.archive-it.org/7993/20170723144330/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101490.pdf.
8. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm.
9. Figures are accurate as of April 20, 2018.
10. Xu, Liang et al. “A Meta-Analysis of Combination Therapy versus Single-Agent Therapy in Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer: Results from Nine Randomized Phase III Trials.” OncoTargets and therapy 9 (2016): 4061–4074. PMC. Web. 8 Feb. 2018.