ERLEADA shows survival benefit in prostate cancer study

LISBON - Johnson & Johnson (NYSE: JNJ) today announced results from a comparative study indicating that its drug ERLEADA® (apalutamide) significantly improved overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) over enzalutamide. The findings were presented at the 6th European Congress of Oncology Pharmacy in Lisbon.

The retrospective study, which adhered to U.S. Food and Drug Administration (FDA) real-world evidence guidelines, included nearly 4,000 patients who initiated treatment with either ERLEADA® or enzalutamide between December 16, 2018, and December 31, 2023. At 24 months, the risk of death for patients who started on ERLEADA® was 23 percent lower than for those who began treatment with enzalutamide.

The study's methodology and diverse patient cohort aimed to ensure the reliability of the results. According to Dr. Neal Shore, Medical Director at the Carolina Urologic Research Center and study investigator, the real-world evidence provides a significant and clinically meaningful survival improvement with apalutamide over enzalutamide at 24 months. He added that while randomized controlled trials are the standard for comparing oncology medicines, this study provides valuable insights for prescribers when selecting an androgen receptor pathway inhibitor (ARPI).

Luca Dezzani, M.D., U.S. Vice President, Medical Affairs, Solid Tumors at Johnson & Johnson, highlighted ERLEADA® as the only ARPI with demonstrated survival benefits as early as 22 months, as observed in the TITAN study. He emphasized the importance of this evidence in supporting ERLEADA® as a treatment option.

The study also acknowledged limitations such as potential miscoding or missing information in the data sources. However, the sources were considered fit for the purpose of correctly identifying the patient population and assessing survival. The company noted that while the 24-month survival data is promising, longer-term studies are necessary to fully evaluate the therapeutic effects of these treatments.

Prostate cancer affects approximately 300,000 individuals annually in the U.S., and despite treatment advances, the risk of disease progression and death remains significant. ERLEADA® is approved by the FDA for the treatment of nmCRPC and mCSPC, offering a once-daily, single-tablet regimen.

The information reported is based on a press release statement from Johnson & Johnson.

In other recent news, Johnson & Johnson has made significant strides in the treatment of multiple myeloma. The company submitted a supplemental Biologics License Application to the FDA for a new indication of its DARZALEX FASPRO® treatment. The application is supported by Phase 3 CEPHEUS study results, which showed that 60.9% of patients achieved minimal residual disease-negativity using the DARZALEX FASPRO® combination, reducing the risk of disease progression or death by 43% compared to an alternative regimen.

In addition to this, the company announced the expansion of its TECNIS Odyssey intraocular lens across the U.S., aimed at enhancing vision for cataract patients. On the legal front, Johnson & Johnson's subsidiary, Red River Talc LLC, filed for a prepackaged Chapter 11 bankruptcy as part of a strategy to settle ongoing ovarian cancer claims related to cosmetic talc litigation in the U.S.

In the realm of executive appointments, the company announced the retirement of Executive Vice President and Chief Human Resources Officer, Dr. Peter M. Fasolo, with Kristen Mulholland named as his successor. Goldman Sachs reiterated its Buy rating on shares of CG Oncology following new data presented by Johnson & Johnson. These are the recent developments at Johnson & Johnson.

InvestingPro Insights

Johnson & Johnson's (NYSE: JNJ) recent study results for ERLEADA® align well with the company's strong market position and financial health. According to InvestingPro data, J&J boasts a substantial market capitalization of $389.95 billion, reflecting its status as a major player in the pharmaceutical industry.

The company's financial strength is evident in its revenue growth, with a 5.13% increase over the last twelve months to $86.58 billion. This growth supports J&J's ability to invest in critical research and development projects like the ERLEADA® study.

InvestingPro Tips highlight J&J's stability and appeal to investors. The company has raised its dividend for 53 consecutive years, demonstrating a commitment to shareholder returns that complements its focus on medical advancements. Additionally, J&J's stock generally trades with low price volatility, which may be attractive to investors seeking stability in the healthcare sector.

The company's profitability is also noteworthy, with a gross profit margin of 69.43% in the last twelve months. This robust profitability provides J&J with the resources to continue funding important clinical studies and product developments like ERLEADA®.

For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Johnson & Johnson, providing a comprehensive view of the company's financial health and market position.

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