Significantly prolongs the lives of prostate cancer patients, Novartis targeted radiotherapy reaches the phase 3 clinical endpoint

▎Editor of WuXi AppTec's content team On March 23, Novartis announced that its potential "first-in-class" targeted radioligand therapy (RLT) 177Lu-PSMA-617 is in the treatment of stage 3 of patients with advanced prostate cancer.
A dual primary endpoint was reached in clinical trials.

Compared with the best standard treatment, 177Lu-PSMA-617 significantly improved the overall survival (OS) and radiological progression-free survival (rPFS) of patients with metastatic castration-resistant prostate cancer (mCRPC).

Novartis expects to submit regulatory applications to the United States and the European Union this year.

Prostate cancer is the second most common type of tumor in men worldwide.

In the past ten years, the incidence of prostate cancer in China has been on the rise, and it has now become the fifth most common cancer among Chinese men.

mCRPC is a serious type of prostate cancer.
The patient's cancer has spread to other parts of the body, and even if the androgen in the body has been reduced to a very low level, the tumor continues to proliferate.

The 5-year survival rate of mCRPC patients is approximately 15%, and they have limited treatment options and have significant unmet medical needs.

Radioligand therapy combines radioisotopes with molecules that can bind to specific biomarkers expressed by tumors.
It is one of the technology platforms that Novartis has focused on developing.
It is compatible with targeted therapies, immunotherapy, and cells and genes.
Therapies are listed as the four major technology platforms for Novartis oncology drug development.

Novartis has been in this field for a long time.
At present, the company's R&D pipeline has more than 15 R&D projects dedicated to the development of a new generation of radioligand anti-cancer therapies.

It has acquired Advanced Accelerator Applications, a company dedicated to the development of radiopharmaceuticals, and its FDA-approved polypeptide receptor radionuclide therapy Lutathera.

Recently, the company invested in Aktis Oncology, a start-up company dedicated to the development of alpha particle-based radiotherapy.

▲Radioligand therapy is one of the four major technology platforms developed by Novartis' anti-cancer drugs (picture source: Novartis' official website).
In the past, radiotherapy of cancer has always used external delivery of radiation as the main treatment method.

The radioligand therapy delivers radioisotope-carrying drugs into the patient's body, and specifically binds to the biomarkers expressed by the tumor to release radiation energy in the tumor to kill the tumor cells.

177Lu-PSMA-617 is a radioligand therapy candidate obtained by Novartis in 2018 when it acquired Endocyte for US$2.
1 billion.

It combines 177Lu with a targeted drug that can bind to prostate-specific membrane antigen (PSMA).

PSMA is highly expressed in more than 80% of prostate cancers, so it is a promising therapeutic target.

The radiation released by 177Lu-PSMA-617 can only work in a short distance, thus limiting the damage to surrounding healthy cells.

▲Introduction to 177Lu-PSMA-617 therapy (picture source: Novartis official website) In a randomized, open-label phase 3 clinical trial called VISION, patients with PSMA-positive mCRPC received 177Lu-PSMA-617 or the best standard therapy.

These patients have been treated with taxane or androgen receptor targeted therapy, but the disease continues to progress.

The test results showed that 177Lu-PSMA-617 reached the dual primary endpoints of significantly improving overall survival and radiological progression-free survival.

The specific data will be announced at the upcoming medical conference.

"The 5-year survival rate of mCRPC patients is less than one-sixth, and they urgently need new treatment options.

These breakthrough data prove the potential of 177Lu-PSMA-617, and we plan to submit these data to regulatory agencies as soon as possible.

" Novartis Chief Medical Officer Said Dr.
John Tsai, official and head of global drug development.

 Reference: [1] Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostatecancer.
Retrieved March 23, 2021, from novartis-announces-positive-result-phase-iii-study-radioligand-therapy-177lu-psma-617-patients-advanced-prostate-cancer[2] Novartis Oncology Pipeline Update.
Retrieved March 23,2021, from https:// www.
novartis.
com/sites/www.
novartis.
com/files/2020-06-novartis-oncology-pipeline-update-presentation.
pdf Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

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