The Current State of Lu-177 based Therapeutics

Cancer is widespread in all population groups and the success of any new therapeutic options will depend on availability and affordability of diagnosis and treatment. Many strategies are used to treat cancers; this includes surgery, radiation, chemotherapy and targeted therapy. Surgery is preferred when the cancer is highly localized and a wide range of advanced technologies including minimally-invasive approaches, robotics and image-guided techniques are adopted. Radiation therapy is used to treat both localized as well as metastatic cancers. Both surgery and radiation therapy causes damage to surrounding tissues. Chemotherapy treatment is relatively unspecific because toxic molecules that cause damage in fairly equal measure to cancer and normal cells.

To overcome the problems associated with other therapies, targeted radiation therapy is used and it is an advanced technology involving a molecule as a targeting agent designed to deliver radiation in the form of radioactive isotopes directly to the tumor in a highly specific and selective way. Lu-177 is one of the emerging and highly pursued radiopharmaceuticals in cancer therapy because of various favorable factors. Lu-177 is an important radioisotope used for both diagnosis and therapy (targeted radionuclide therapy) as its half-life (6.647 days) makes it easier to combine with numerous biologically active compounds like mAb and peptides and supply to hospitals relatively safely.

Some of the drivers favoring adoption of Lutetium-177 are, increase in the incidence and prevalence of neuroendocrine tumors, prostate and other cancers and clinical use of the Lu-177 agent is expanding in several countries. However, high cost for the treatment for targeted therapy using Lu-177, side effects such as diarrhea, and availability of alternative therapies such as relatively less expensive chemotherapy, hormone therapy, radiation therapy and surgery are the restraining the market growth.

The important factor in promoting Lu-177 as a therapeutic radionuclide is the success achieved in several countries in treating patients suffering from neuroendocrine tumors with somatostatin receptor (SSTR)-targeted Lu-177 labeled peptides. The Lu-177 therapy has been shown to slow down or prevent tumor growth and it increased life expectancy and improves the quality of life with neuroendocrine tumors.

A large number of the Lu-177 based molecules being developed for the treatment of cancer. For example, Novartis Company is the leading developer of Lu-177 based therapy with 4 molecules such as Lu-177-PSMA-617, Lu-177-NeoB, Lu-PSMA-R2 and Lu-177-FF-10158. This has been successfully established in the case of GEP-NET and prostate cancer because in the case of GEP-NET the cells express somatostatin receptors (SSTR) and in the case of prostate cancer the cells express prostate-specific membrane antigen (PSMA).

Currently, there is only one FDA, CE and Health Canada approved Lu-177 based drug (Lutathera Lu-177-DOTATATE) for GEP-NET treatment including hindgut, midgut and foregut and it is administered for 2nd line and 3rd line GEP-NET treatment eligible patients.

The growing interest in Lu-177 is fuelling many product approvals, acquisitions and collaboration agreements. For instance, In November 2019, ITM Isotopen Technologien Munchen AG entered into a license agreement with CIRC’s subsidiary Gatong. Under the terms of the agreement, ITM will provide EndolucinBeta to CIRC. In December 2018, Novartis acquired Endocyte for its radioligand therapy (RLT) candidate Lu-177-PSMA-617 which is in the Phase III development stage for prostate cancer. This deal strengthened Novartis leadership in nuclear medicine and radioligand therapy for treating cancer.

Pipeline analysis reveals that there are about 30 molecules in various stages (focused on Discovery, Preclinical, Phase I, II and III). The most number of molecules were in Phase 2 stage of clinical development with 12 molecules, followed by phase 1 with 10 molecules, Pre-clinical with 4 molecules, Phase 3 with 3 molecules and discovery with one molecule including Radio-immunotherapy (RIT) and Peptide Receptor Radionuclide Therapy (PRRT). Total number of Clinical trials based on indications is 37. Out of that, 9 molecules are for prostate, 8 molecules are for GEP-NET and the remaining 20 molecules for other indications such as Thyroid, ovarian, bone, colorectal and others.

Considering the attractiveness of Lu-177 based therapy, several venture capitalists are aggressively investing. According to IQ4I analysis, funding received by companies during the period 2018-2020 worth ~$99.0 million. For example, In February 2020, ITM Isotopen Technologien received $43.6 million in funding from the European Investment Bank.

Some of the major players of Lutetium-177 Pipeline analysis are Novartis AG (Switzerland), ITM Isotopen Technologien Munchen AG (Germany), Nordic Nanovector (Norway), Telix Pharmaceuticals Ltd (Australia), Cell Point, L.L.C. (U.S.), RadioMedix, Inc. (U.S.), 3B Pharmaceuticals GmbH (Germany) and others.

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