Understanding Cancer at the Molecular Level
Our understanding of cancer at the molecular level has expanded rapidly in recent decades. We now know that cancers are complex diseases caused by abnormalities in the genetic material of healthy cells. These abnormalities allow cells to grow and divide in an uncontrolled way, forming tumors that can spread and invade other parts of the body. Researchers have identified numerous genetic mutations and dysregulated molecular pathways that drive the development and progression of different cancer types. This improved biological understanding laid the foundation for a new class of targeted cancer therapies known as biologics.
The Emergence of Biologic Therapies
Biologics, also called biological drugs, are medicines made from living organisms or contain components of living organisms. Unlike chemotherapies that work throughout the body in a non-specific manner, biologics are designed to specifically target molecular changes that fuel cancer growth and survival. Some of the first biologics approved for cancer included monoclonal antibodies such as Trastuzumab (Herceptin) for HER2-positive breast cancer. Others included cytokines such as Interferon for melanoma and renal cell carcinoma. These early biologics demonstrated that directly targeting cancer's underlying molecular drivers could improve clinical outcomes for certain patient subgroups.
Expanding Options Across Cancer Types
Over the last two decades, Cancer Biologics therapies have expanded rapidly as scientists identified new molecular targets and pathways involved in different cancer types. Today, biologics are approved for several cancers including lung cancer, skin cancer, blood cancers, gastrointestinal cancers, genitourinary cancers, head and neck cancers and others. Popular classes of biologics include monoclonal antibodies, immune checkpoint inhibitors, antibody-drug conjugates, cancer vaccines and cellular therapies. Leading biologics across different cancer types include Pembrolizumab (Keytruda), Nivolumab (Opdivo), Atezolizumab (Tecentriq), Rituximab (Rituxan), Bevacizumab (Avastin), Cetuximab (Erbitux), Trastuzumab (Herceptin) and Tisagenlecleucel (Kymriah). Some biologics are used alone while others are combined with chemotherapy, immunotherapy or targeted oral drugs as part of multi-pronged treatment regimens
Biologics Transform Treatment Paradigms
The availability of biologic therapies has transformed treatment paradigms for many cancer types. Where previously chemotherapy was the mainstay of treatment, biologics now allow oncologists to select therapies based on specific molecular characteristics of each patient’s tumor. This has led to improved clinical outcomes for subsets of ‘molecularly-selected’ or biomarker-defined patients. For example, Trastuzumab revolutionized outcomes for HER2-positive breast cancer patients with a 30% reduction in the risk of death. In lung cancer, targeting EGFR mutations with drugs like Osimertinib leads to unprecedented response rates of over 60%. Immunotherapies have also succeeded where chemotherapy often fails, extending patient lifespan and in some cases providing potential cures for previously incurable cancers like melanoma.
Fueling a Multi-Billion Dollar Industry
Cancer biologics have fueled the rise of a multi-billion dollar global oncology therapeutics industry. Analysts estimate the global cancer biologics market was worth over $100 billion in 2019 and expected to grow substantially in the coming decade driven by drug approvals, rising drug prices and improved access. Leading biologics regularly rank among the world’s top selling drugs. For instance, Keytruda sales of over $11 billion in 2019 made it the highest grossing oncology drug worldwide. Success of blockbusters like Herceptin, Avastin and Rituxan demonstrated revenues of billions annually for their manufacturers Roche and Genentech for many years. Fierce competition exists between large pharmaceutical companies to develop the next breakthrough biologic as the economic potential is immense. Global spending on cancer drugs as a whole is projected to reach $200 billion by 2023.
Frontiers of Discovery: Combinations and Next-Gen Platforms
Despite advances, there remains significant unmet need as most cancer patients will eventually develop resistance to existing monotherapies. Researchers are pursuing novel combination strategies and next-generation biologic platforms that could change the treatment landscape yet again in coming years. Areas of active research include combining biologics that target different pathways, combining biologics with immunotherapies, engineered cellular therapies and gene therapies. Other investigational approaches involve bispecific antibodies, antibody-drug conjugates and nanoparticles. Sustained progress will require large collaborative trials to test myriad combination strategies across biomarker-defined cancer subtypes. Success in these frontiers promises to usher in another wave of tailored, less toxic and potentially curative options for the many patients who currently have limited treatment choices. The era of cancer precision medicine through innovative biologic platforms is still in its infancy but holds enormous promise to transform outcomes if realized.
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