The Italian Medicines Agency (Aifa) has approved reimbursement for apalutamide, an anticancer drug androgen receptor inhibitor tablets, developed by Janssen – a Johnson & Johnson Group pharmaceutical company – for the treatment of adult men with hormone-sensitive metastatic prostate cancer (mHspc) in combination with androgen deprivation therapy (Adt). The drug was already reimbursed in non-metastatic castration-resistant prostate cancer (nmCrpc).
Apalutamide, produced in Italy at the Janssen plant in Latina for the European market and other continents, has a powerful antitumor activity, obtained by causing the death (apoptosis) of cancer cells and thus reducing their proliferation. The drug blocks the androgen receptors to which testosterone, which is the hormone used by prostate cancer, binds to develop.. Apalutamide, well tolerated, demonstrated a 48% reduction in the risk of death and an improvement in secondary progression-free survival by 38%, delaying the onset of resistance to castration as the disease worsened.
Prostate cancer, in Italy, is the most frequent malignancy among males and represents over 20% of all cancers diagnosed from the age of 50. There are currently around 564,000 fellow countrymen with this diagnosis, accounting for 33% percent of cancers in men. In 2020, around 36,000 new cases were estimated (19% of all male cancers). Most of the diagnoses are in people of advanced age, 6,811 cases per 100,000 in fact concern men over 65 years of age. The majority live in the North (1,428 cases per 100,000 inhabitants in the North-West, 1,395 in the North-East) compared to the Center (1,015) and the South (588).
“The reimbursement of apalutamide for patients with mHspc represents news that Italian oncologists have been waiting for for some time. For years, the only strategy available in Italy in this phase of the disease has been the addition of docetaxel chemotherapy to androgen deprivation therapy. With the reimbursement of apalutamide we can finally offer our patients a therapeutic alternative with clear efficacy and a favorable tolerability profile“, He clarifies Orazio CaffoDirector of the Medical Oncology Operating Unit, Trento Hospital.
“The advantage of this treatment in terms of overall survival – underlines the oncologist – is evident and it is all the more so if we consider that a significant number of patients in the control arm have made the cross-over, that is, they received apalutamide after the opening of the blind. But the benefit is also evident considering the subsequent treatments that sequentially administered confirm the effectiveness of the drug. Apalutamide, whose handling we had already had the opportunity to appreciate in the nmCrpc, it was also well tolerated in these patients with advanced disease with a clear benefit in terms of quality of life. The introduction of apalutamide in clinical practice – he concludes – represents a further step forward in the progress of these years that now allow our patients with prostate cancer to face their disease with greater serenity “.
“If it is true that prostate cancer is the most common cancer in men, it is equally true that, in recent years, the increase in knowledge and new treatment solutions have allowed a drastic reduction in mortality and a significant increase in life expectancy“, He declares Vincenzo MironeHead of the Resources and Communication Office of the Italian Society of Urology (Siu), full professor and director of the School of Specialization in Urology at the Federico II University of Naples and president of the Pro Foundation. “The drug apalutamide – he adds -, already available for some years in Italy for the treatment of non-metastatic prostate cancer resistant to castration, has in fact been shown to significantly reduce the risk of metastasis and death “.
“Prostate cancer,” he says Maria Laura De Cristofaro, volunteer president of Europa Uomo, “is a very widespread disease with high social costs. If, as an oncology voluntary association founded with great foresight by Professor Umberto Veronesi, our mission is, first of all, to inform and raise awareness of the importance of early diagnosis of this male cancer, with equal resolve, we support the efforts of scientific research towards better and, if possible, decisive treatments. We therefore very much welcome the availability in Italy of this important drug – he continues – which can concretely strengthen the prospects of a cure for patients suffering from prostate cancer “.
“For over 30 years Janssen Oncology has invested in scientific research for the development of innovative drugs that meet the care needs of patients and to support doctors in the treatment of hematological and solid cancers, such as prostate cancer,” he says. Daniela Curzio, Therapeutic area oncology Medical manager Janssen Italia. “The reimbursement of apalutamide in hormone-sensitive prostate cancer – he observes – is a further step forward in the definition of non-chemotherapy oncological therapies in Italy, a commitment of Janssen that has become one of the cornerstones of our mission”.
The efficacy and safety of apalutamide were determined in two randomized, placebo-controlled, phase 3 studies: studio Spartan (relative to the nmCrpc indication) and lo studio Titan (for the mHspc indication).
Non-metastatic castration resistant prostate cancer is a stage of the disease that no longer responds to treatments that lower testosterone. However, 90% of patients with nmCrpc will develop metastases. In this form, data from the Spartan study showed that apalutamide, in combination with androgen deprivation (Adt), reduces the risk of death by 22%, compared to Adt alone, and significantly prolongs the median overall survival by 14 months, which becomes 21. , applying the correction for the cross-over of patients who, in the placebo arm, took apalutamide at the opening of the blind because of the evident superiority of the experimental arm.
Even more important are the results obtained by apulatamide – as evidenced by the Titan study – in hormone-sensitive metastatic prostate cancer, a stage of the disease in which the cancer still responds to Adt, but has already spread to other parts of the body. Patients with mHspc tend to have a poor prognosis, with a median overall survival (Os) of less than five years. Data from Titan demonstrate that apalutamide in combination with Adt, at a median follow-up of nearly four years, reduces the risk of death by 35% compared to androgen deprivation alone; applying the correction for patient crossover in the placebo arm, this reduction increases to 48%. In addition, the drug improves secondary progression-free survival (Pfs2) by 38% and delays the onset of resistance to castration which worsens the situation. The latter finding suggests that early intensification of apalutamide therapy can positively influence the course of the disease for patients who subsequently undergo chemotherapy or are treated with new hormonal agents.
Apalutamide is well tolerated, maintains a good quality of life during treatment, delaying the use of cytotoxic chemotherapy and its impacting side effects over time, as also highlighted by the 73% reduction in the risk of Psa progression, an indicator of disease progression.