A New Era in Cancer Treatment: Unveiling 10 Revolutionary Drugs from Darzalex to DS-8201, the Numbers Behind Extending Lives

In the current field of commercial products, PD-1 drugs in the field of solid tumor treatment occupy a dominant position, at the same time, a variety of other therapies also show their unique advantages. The interwoven development of these therapies has together written a magnificent chapter in the long struggle against cancer.

As the market leader, K drug not only dominates the field of oncology drugs, but also ranks first in the global drug sales list in the first half of 2024. It has been ten years since 2014, when the US Food and Drug Administration (FDA) accelerated approval of its melanoma indication. As of June 17, 2024, 40 indications have been approved for drug K. The O drug, followed by the approval of the market in 2015, also takes melanoma as a starting point, and continues to expand in the field of tumor treatment.

PD-1 therapy represents a generational leap in oncology drug research by activating T cell immune processes to fight cancer cells. The therapy has a wide range of combined application potential, and the combination of chemotherapy, antibody drug conjugate (ADC), small molecule targeting drugs and even new Chinese medicines has brought a new idea for cancer treatment.

In the field of hematoma treatment, the CD38 monoclonal antibody Darzalex has changed the landscape of myeloma treatment. The drug was launched in late 2015, becoming the world's first approved monoclonal antibody for CD38. Its treatment regimen has advanced from the back line to the front line, rapidly covering multiple myeloma treatment from the fourth line to the first line, largely replacing the traditional small molecule drug lenalidomide, which is No.6 Revlimid in the list.

Johnson & Johnson's BTK inhibitor ibrutinib, as a pioneer of small molecule inhibitors, is also epoch-making. At the same time, Zeebutinib, a subsidiary of China's "first innovative drug brother", has also joined the competition. Patents on both drugs are about to expire, with ibrutinib's compound patent set to expire in 2026 and Darzalex's patent set to expire in 2029. Johnson & Johnson is already laying out the next generation of therapies, breaking new ground in hematoma with Legend Biotech's CAR-T therapy.

For solid tumors, in addition to PD-1 monoclonal antibody, drugs targeting tumor cell targets are highly targeted and may be studied in depth on specific several solid tumors. Most of today's sales leaders are derived from pipeline layouts from 10 years ago, so you can see many of the popular monoclonal antibody layouts at the time, which are aligned with the current cutting edge dual antibody and ADC drugs.

As a third-generation small molecule drug targeting EGFR, Tagrisso (Ohitinib) has solved many problems of the first two generations of drugs and rapidly promoted the number of treatment lines, and has become a first-line drug for non-small cell lung cancer (NSCLC). Current research and development is focused on addressing resistance to ocitinib, which is often used as a control in Phase III clinical trials. The recently launched deuterated small molecule drug from Homekonil and the recently announced EGFR/c-MET dual antibody from Johnson & Johnson address this challenge.

Xtandi is an outstanding representative of the era of small molecule medicine. Since it was first approved in 2012, it has been used to treat prostate cancer because it specifically blocks the function of androgens binding to receptors. The classic treatment is in combination with leprerelin, which is androgen deprivation therapy (ADT). At present, prostate cancer indications have become an important platform for RDC drugs. Breast cancer and prostate cancer, as gender-specific cancers, are special in men and women. Breast cancer has the second highest incidence in women, and HER2 is an important target of breast cancer. Clinically, breast cancer is usually divided into three types: zero HER2 expression, low HER2 expression and HER2 positive expression. If the HER2 target of breast cancer patients is positive, treatment options will be more abundant, among which Perjeta (Pertuzumab), as an outstanding representative of targeted drugs, is used in combination with trastuzumab to jointly act on the HER2 target. It is worth noting that the U.S. patent for trastuzumab expired in 2019, and the current market competition is mainly focused on biosimilars.

Verzenio (Abesili), as another important drug in the treatment of breast cancer, is a small molecule kinase inhibitor that affects the cell cycle and cancer cell proliferation by inhibiting CDK 4/6 activity. However, the drug is mainly suitable for patients with hormone receptor (HR) positive breast cancer, and has significant efficacy for types of breast cancer that are HR positive but HER2 negative.

The current sales of leading cancer drugs represent the wisdom of the previous generation of developers, and build a complete system of cancer treatment. Just as contemporary developers are tackling challenges in the field of ADC, multi-antibody, CAR-T and other therapies, the efforts and dedication of each generation ultimately translate into longer survival of cancer patients.

In the HER2 target segment, DS-8201 is an emerging force in ADC drugs, with sales reaching $1.772 billion in the first half of 2024, a significant increase from $1.2 billion last year. The drug is not limited to breast cancer, receiving FDA approval for gastric cancer in January 2021, and its development pipeline also includes non-small cell lung cancer and colorectal cancer.

Targeting the breast cancer indication, Trodelvy, the trop2 ADC, offers new therapeutic promise for patients with triple-negative breast cancer. The drug received accelerated FDA approval in 2020 with Phase I/II trial results, making trop2 ADC a hot target in the ADC field after HER2, on par with nectin-4.

In the field of hematoma treatment, CAR-T therapy has completely changed the treatment landscape of multiple myeloma. At present, the research and development of CAR-T therapy is focusing on autoimmune diseases and solid tumors, which is expected to bring new treatment hope for glioblastoma, a stubborn cancer. The current treatment for this intracranial tumor is still stuck in the chemotherapy stage of many years ago, although there have been advances in electric field therapy in recent years.

Legend Biotech's CAR-T drug, Cedarkeolenxel, is expected to become a new sales star in the coming years, and the key is approval of the first-line treatment. If the acquisition news is confirmed, it will likely have a positive impact on the advancement of the Sidagiolencel indication.

One of the development directions of PD-1 is dual antibody. As a representative enterprise, Kangfang Biologic's AK-104 (PD-1/CTLA-4 double antibody) and AK112 (PD-1/VEGF double antibody) are both innovative drugs on the market. AK-104 is the first marketed PD-1/CTLA-4 dual antibody, and AK112 is the first marketed PD-1/VEGF dual antibody.