Formycon announced start of clinical phase III trial for Keytruda biosimilar candidate FYB206

Formycon AG announced that the first patient has been enrolled in the Phase III clinical trial “Lotus” to compare the safety and efficacy of FYB206/pembrolizumab with the immuno-oncology blockbuster drug Keytruda (First Patient In).

The double-blind, multicenter “Lotus” study is evaluating the best overall response rate (bORR) in patients with non-small cell lung cancer (NSCLC). The comparative treatment comprises up to 17 treatment cycles within 40 weeks. Changes in tumor size will be continuously documented during this period using imaging techniques. Following the comparative treatment, the therapy will be continued for an additional 12 months.

The study design was developed in close coordination with the regulatory authorities U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The trial is being conducted in several countries in Eastern Europe and Southeast Asia and is running in parallel to the Phase I study, which started in mid-June, comparing the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda in patients with malignant melanoma (black skin cancer).

“Immuno-oncology is a relatively young field in cancer therapy and is seen as a great hope for many patients. Pembrolizumab has already demonstrated its efficacy in numerous types of cancer. Additionally, several studies are currently underway to expand the range of indications. This alone highlights the enormous potential of our pembrolizumab biosimilar candidate FYB206 – both in medical and economic terms. In fact, sales of Keytruda, currently the world’s best-selling drug, are also continuing to grow.

The start of the Phase III clinical trial represents an important milestone for us in order to provide an effective, safe and cost-effective treatment option for many severely ill cancer patients worldwide in the future,” – comments Dr. Andreas Seidl, Chief Scientific Officer (CSO) of Formycon AG.

Non-small cell lung cancer is one of numerous cancer diseases for which the immune checkpoint inhibitor pembrolizumab is indicated. In a wide variety of cancers, cancer cells manage to inhibit the body’s own immune defenses by manipulating so-called immune checkpoints. Pembrolizumab, which targets the immune checkpoint PD-1, ensures that the body’s own T cells can again fight and kill the cancer cells.

Due to the increasing use of the active ingredient in earlier stages of cancer and the continuing high global demand, sales of Keytruda increased by 20% year-on-year in the first quarter of 2024.3 As a result, sales of this currently best-selling drug could rise to USD 30 billion worldwide by 2026.4

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently anticipates the earliest market entry of FYB206 after the expiry of the market exclusivity of the reference product in the USA from 2029 and in the EU from 2030. First results of the Phase I trial are expected in 2026. Preliminary results of the Phase III trial are to follow in the course of 2027.

About Formycon

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange. Further information can be found here.