Cancer Deaths Down 9% in Italy: New Immunotherapy Advances Approved

Recent advancements in cancer treatment are offering new hope to patients, with a reported 9% decrease in cancer-related deaths in Italy over the past decade. This positive trend is attributed to increased preventative measures, wider participation in screening programs, and innovative therapies, particularly in the field of immunooncology.

Breakthroughs in Immunotherapy Receive Regulatory Approval

The Italian Medicines Agency (AIFA) has recently approved reimbursement for pembrolizumab in three new indications, adding to its existing 25 approved uses. These approvals represent a significant shift in clinical practice for certain gynecological and urological cancers.

Cervical Cancer Treatment Advances

For patients with locally advanced cervical cancer (stage III-Iva, according to the FIGO 2014 classification), the addition of pembrolizumab to chemoradiotherapy has demonstrated promising results. According to study findings, this combination therapy reduced the risk of death by 43% in these patients.

“For the first time in 25 years, clinical practice is changing in the treatment of locally advanced, high-risk cervical cancer, where the standard of care has historically been chemoradiotherapy alone,” says Domenica Lorusso, Head of the Gynecological Oncology Center at Humanitas San Pio X and Professor of Obstetrics and Gynecology at Humanitas University. “The combination of pembrolizumab with concurrent chemoradiotherapy significantly and clinically increases overall survival.”

Data published in The Lancet showed a 33% reduction in the risk of death with the combination therapy compared to chemoradiotherapy alone. The overall survival rate at 36 months was 82.6% for the combination group versus 74.8% for those receiving chemoradiotherapy alone. In patients specifically classified as stage III-Iva (FIGO 2014), the risk of both progression and death was reduced by 43% with the addition of pembrolizumab.

Lorusso emphasizes that this represents a potentially curative setting. “Adding immunotherapy with pembrolizumab to chemoradiotherapy will allow more patients to achieve potential cure. This approach combines the long-term benefits of immunotherapy with the immediate effectiveness of chemoradiotherapy, which have demonstrated a synergistic effect in other diseases when administered together.”

Endometrial Cancer: A New First-Line Treatment Option

In 2024, nearly 2,400 new cases of cervical cancer were estimated in Italy. The vast majority of these cases are caused by infection with the Human Papillomavirus (HPV), primarily transmitted through sexual contact.

AIFA has also approved pembrolizumab, in combination with chemotherapy (carboplatin and paclitaxel), as a first-line treatment for patients with primary advanced or recurrent endometrial carcinoma with mismatch repair deficiency (dMMR). A study, Keynote-868, revealed that pembrolizumab plus carboplatin and paclitaxel, followed by pembrolizumab monotherapy, reduced the risk of disease progression or death by 66% in patients with mismatch repair deficiency compared to placebo plus chemotherapy followed by placebo alone.

“Endometrial carcinoma is one of the most common cancers affecting women, and We see the only gynecological cancer with an increasing incidence and mortality rate,” notes Lorusso. “Unfortunately, the median survival for patients with recurrent or advanced disease is not more than 36 months. Molecular characterization is crucial and impacts therapeutic choice. Approximately 30% of patients have a tumor with mismatch repair deficiency, indicating a malfunction in DNA repair mechanisms. Adding pembrolizumab to chemotherapy represents a new first-line therapeutic option for women with advanced or recurrent primary endometrial carcinoma with mismatch repair deficiency, demonstrating a truly significant improvement in progression-free survival. This is an extraordinary result.”

Urothelial Carcinoma: A Paradigm Shift in First-Line Therapy

After decades of reliance on platinum-based chemotherapy, the treatment of first-line advanced or metastatic urothelial carcinoma is also evolving. AIFA has approved reimbursement for pembrolizumab in combination with enfortumab vedotin, an antibody-drug conjugate.

The Keynote-A39 study, published in the New England Journal of Medicine, compared the new combination to platinum-based chemotherapy, the standard of care for decades. The study demonstrated a significant and clinically relevant benefit in both progression-free survival and overall survival. At a median follow-up of 29.1 months, the combination reduced the risk of death by 49%, with median overall survival more than doubled compared to chemotherapy.

The median duration of response was 23.3 months for the combination therapy and 7 months for chemotherapy. Approximately 31,000 new cases of bladder cancer were estimated in Italy in 2024, with over 90% being urothelial carcinomas.

Roberto Iacovelli, Associate Professor of Medical Oncology at the Catholic University of the Sacred Heart, Policlinico Universitario Agostino Gemelli IRCCS in Rome, explains, “Since the 1980s, platinum-based chemotherapy regimens have been the standard of care for non-resectable or metastatic urothelial carcinoma. The new combination, for the first time, has improved survival and disease control. We are facing a true revolution in care and a decisive innovation for patients, both for the results obtained and for the nature of the treatments.”

Iacovelli further explains that pembrolizumab had already proven effective as a second-line therapy for urothelial cancer. “In first-line treatment, the combination of pembrolizumab plus enfortumab vedotin is characterized by synergy in disease control, to the benefit of patients. The disease is thus countered on two fronts. One is the immune system, which is reactivated against the tumor thanks to pembrolizumab, the other is the greater selectivity in attacking cancer cells, thanks to the antibody-drug conjugate, which constitutes a more evolved form of chemotherapy. This results in more durable and profound control of the neoplasm. Median overall survival has more than doubled, and the efficacy of the therapy in significantly reducing the extent of the disease is possible in a relevant percentage of patients, namely 67% compared to 44% with chemotherapy. Because these results have changed the natural history of the disease, clinical practice will also change, surpassing the old chemotherapeutic standard.”

Nicoletta Luppi, President and CEO of MSD Italy, concludes, “MSD’s immunotherapy with pembrolizumab has marked a quantum leap in oncology, a real paradigm shift that has opened up previously unimaginable paths. The triple expansion of indication by AIFA testifies to the continued value of immunotherapy in transforming clinical practice, offering new therapeutic perspectives to cancer patients. This result stems from a long-term vision and a constant and unparalleled commitment to research, supported by one of the largest clinical development programs in oncology: a diversified pipeline that includes over 25 innovative mechanisms and more than 30 types of cancer. It is this confidence in science, combined with the ability to look ahead, that allows us to imagine a future in which One can continue to offer more time and more life to an increasing number of people.”