Johnson & Johnson New drug: Erleada (apatamide) for prostate cancer (mCSPC)

News

Johnson & Johnson New drug: Erleada (apatamide) for prostate cancer (mCSPC)

Johnson & Johnson New drug: Erleada (apatamide) for prostate cancer (mCSPC)

New drug for metastatic castration-sensitive prostate cancer (mCSPC)! Johnson & Johnson Erleada (apatamide) long-term treatment: prolong life and maintain quality of life!

Johnson & Johnson (JNJ)’s Janssen Pharmaceuticals recently announced that the prostate cancer drug Erleada (Apalutamide, common name: apalutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) Phase III TITAN study pre-designated the final analysis Patient report outcome (PRO) data.

Johnson & Johnson New drug: Erleada (apatamide) for prostate cancer (mCSPC)

The results of the previous study showed that: with a median follow-up of 44 months, compared with patients receiving placebo + androgen deprivation therapy (ADT), patients receiving Erleada + ADT had statistically significant overall survival (OS) The significant benefits.

The new PRO data shows that adding Erleada to ADT maintains the patient’s health-related quality of life (HRQoL) and does not increase the burden of side effects, which is consistent with the use of ADT alone.

Erleada is a new generation of androgen receptor (AR) inhibitors that can help block the activity of male hormones (such as testosterone hormone) and delay the progression of the disease. In terms of prostate cancer, Erleada has been approved for 2 indications: treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). These two indications have been approved in China.

The lead researcher of TITAN and Neeraj Agarwal, MD, of the Huntsman Cancer Institute (HCI) of the University of Utah, said: “Worries about side effects and their burden on quality of life may become an obstacle for patients when considering treatment options. What we see The significant long-term overall survival benefit of Erleada that has no effect on the patient’s quality of life emphasizes the important role of this therapy in the treatment of advanced prostate cancer.”

Compared with the placebo+ADT treatment group, the Erleada+ADT treatment group had no significant difference in quality of life.

In general, the two groups of patients reported relatively asymptomatic and had good baseline HRQoL; the short-form pain scale (BPI-SF) and the functional assessment of prostate cancer (FACT-P) questionnaire were used to evaluate the outcome.

On the BPI pain severity level 0 (no pain/interference in daily activities) to 10 (most severe pain/interference), the median score of patients in the Erleada+ADT treatment group was 1.1 points, and the placebo+ADT treatment group was 1 point .

On the FACT-P HRQoL scale (1-156, higher score = better quality of life), the median score of patients in the Erleada+ADT treatment group was 113 points, and that of the placebo+ADT treatment group was 113.3 points.

In addition, according to FACT-P’s assessment, Erleada+ADT has also been proven to maintain physical, social and family, emotional, functional and mental health after 2 years.

There was no significant difference in the median time to deterioration of BPI or FACT-P scores between the groups, which further proved that Erleada can maintain the quality of life.

Previous data showed that Erleada significantly improved overall survival (OS) in the two approved prostate cancer indications (mCSPC [TITAN study], nmCRPC [SPARTAN study]).

The final analysis data of the TITAN study was announced at the ASCO Urogenital Cancer Symposium in 2021, and was recently published in the Journal of Clinical Oncology, reiterating the addition of Erleada to ADT for mCSPC patients.

During follow-up 44 It continued to provide statistically significant OS benefits after months, and reduced the risk of death by 35% compared with ADT alone (HR=0.65; 95%CI: 0.53-0.79; p<0.0001).

The final analysis data of the SPARTAN study was announced at the 2020 ASCO annual meeting, showing that the Erleada+ADT regimen extended the median OS by 14 months compared with placebo+ADT (Erleada group vs placebo group: 73.9 months vs 59.9 months Month), reduced the risk of death by 22% (HR=0.78; 95%CI: 0.64-0.96; p=0.016).

Mary Guckert, Vice President of Prostate Cancer, Janssen Research and Development, said: “Patient Report Outcome (PRO) data provides meaningful information for treatment decisions by providing us with in-depth understanding of patients’ feelings and functions. In patients with metastatic castration-sensitive prostate cancer In China, the provision of therapeutic drugs (such as Erleada) that have significant survival advantages and maintain quality of life is essential.”

Erleada is a new generation of androgen receptor (AR) inhibitors that can help block the activity of male hormones (such as testosterone hormone) and delay the progression of the disease.

In the United States, Erleada was first approved by the FDA in February 2018 for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.

This approval makes Erleada the world’s first drug for the treatment of nmCRPC. In September 2019, the FDA approved a new indication for Erleada for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

In China, Erleada received accelerated approval in September 2019 for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.

In May 2019, the Center for Drug Evaluation (CDE) of the National Medical Products Administration granted Ansenke ® the “priority review” qualification due to its obvious clinical advantages, and included Ansenke ® into the second batch of clinically urgently needed overseas new drugs.

Ansenke ® is the first approved nmCRPC treatment plan in China, and it is also another innovative solution brought by Xi’an Janssen to the domestic prostate cancer field after Zeke ® (abiraterone acetate tablets).

Previously, Zeke® was approved in 2015 and 2018 for use in combination with prednisone or prednisolone to treat mCRPC patients and newly diagnosed high-risk mCSPC patients.

In August 2020, Erleada’s new indication was approved by the National Food and Drug Administration for the treatment of adult patients with metastatic endocrine therapy-sensitive prostate cancer (mHSPC).

It is worth mentioning that in February 2020, Ansenke®’s mHSPC indication was once again granted the “priority review” qualification by the National Medical Products Administration.

The approval of this indication is expected to fill the urgent medical needs of patients with advanced prostate cancer in China.

The world is very optimistic about Erleada’s business prospects. According to the forecast report released by EvaluatePharma, a pharmaceutical market research agency, Erleada’s global sales in 2024 are expected to reach 2.115 billion US dollars.