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American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2023 | iPharmaCenter

Updated: Feb 19, 2023


Niraparib and abiraterone combination prolonged time to symptomatic progression versus placebo in BRCA-positive castration-resistant metastatic prostate cancer patients.

Janssen has presented the second interim analysis of the MAGNITUDE study, a Phase 3, placebo-controlled trial, to evaluate the efficacy of niraparib, abiraterone, and prednisone in patients with BRCA-positive metastatic prostate cancer.

After a median follows of 26.8 months, the combination of niraparib, abiraterone, plus prednisone showed prolongation in time to symptomatic progression and improvements in time-to-initiation of cytotoxic chemotherapy in homologous recombination repair (HRR) positive prostate cancer.

The primary endpoint was radiographic progression-free survival, in which there was a significant improvement versus placebo. In BRCA-group, there was a trend in improvement in overall survival. The rPFS was 19.5 months in the combination versus 10.9 months in the placebo group.

Anemia, hypertension, and constipation were commonly reported adverse events.

An estimated 288,300 new cases of prostate cancer are expected in 2023, causing nearly 35,000 deaths in the US. About 10 to 15% of mCRPC have BRCA gene alternations.



No significant OS improvement was reported with Lynparza plus abiraterone and prednisone combination versus placebo in metastatic castration-resistant prostate cancer.

Merck and AstraZeneca announced the overall survival data of Phase 3 PROpel; the combination of Lynparza plus abiraterone and prednisone failed to demonstrate statistical significance versus placebo in patients with metastatic castration-resistant prostate cancer.

In the trial, Lynparza plus abiraterone combination was evaluated versus placebo plus abiraterone, with radiographic progression-free survival (rPFS) as the primary endpoint and overall survival (OS) as the secondary endpoint.

The median OS was 42.1 months in the Lynparza arm versus 34.7 months in patients on placebo, an absolute improvement of 7.4 months, which is not statistically significant.

The median progression-free survival (rPFS) was 24.8 months in the Lynparza arm versus 16.6 months in patients on a placebo.

The European Commission approved the combination in December 2022 for adult men with metastatic castration-resistant prostate cancer, for whom chemotherapy is unsuitable.



Bayer presented a subgroup analysis of the Phase 3 ARASENS trial, demonstrating the overall survival of darolutamide plus ADT in combination with docetaxel across different populations with prostate cancer.

Bayer presented the subgroup analysis of the Phase III ARASENS trial, in which darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel demonstrated improvement in high and low-volume, as well as high and low-risk metastatic hormone-sensitive prostate cancer versus placebo.

In the Phase III ARASENS trial, the combination of darolutamide, ADT, and docetaxel was evaluated versus placebo plus ADT with docetaxel. The primary endpoint was overall survival.

Darolutamide plus ADT, in combination with docetaxel, showed significant and consistent overall survival in high-risk and low-risk patients. The survival benefit was demonstrated in a smaller group of patients with low-volume disease.


BMS presented three-year follow-up data of the Opdivo plus Cabometyx combination, which showed sustained survival as a first-line therapy for advanced renal cell carcinoma.

Bristol Myers Squibb (BMS) and Exelixis presented three-year survival data of Opdivo (nivolumab) plus Cabometyx (cabozantinib) combination in patients with advanced renal cell carcinoma. The combination showed overall survival, progression-free survival, and objective response versus sunitinib.

BMS stated that CheckMate -9ER is the longest reported follow-up trial of an immunotherapy-tyrosine kinase inhibitor regimen in patients with advanced renal cell carcinoma.

The overall survival in Opdivo plus Cabometyx is 49.5 months versus 35.5 months in patients on sunitinib, a 30% reduction in the risk of death. The progression-free survival was 16.6 months in Opdivo and Cabometyx arm versus 8.4 months in patients on sunitinib. The CR was 12.4% in patients treated with Opdivo and Cabometyx combination versus 5.2% in those treated with sunitinib.

The improvements were observed in both median PFS and OS, irrespective of PD-L1 status.

Opdivo, an adjuvant treatment, showed durable benefits in patients with high-risk muscle-invasive urothelial carcinoma.

Bristol Myers Squibb announced that Opdivo (nivolumab) as an adjuvant treatment demonstrated significant clinical benefits in patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. In patients whose tumor cells express PD-L1 ≥1%, there was a significant improvement in disease-free survival (DFS), non-urothelial tract recurrence-free survival (NUTRFS), distant metastasis-free survival (DMFS) and second progression-free survival (PFS2) versus placebo after a median follow-up of 36.1 months.

Disease-free survival (DFS): Opdivo doubled the average length of time without disease recurrence; the median disease-free survival was 22.0 months in the Opdivo arm versus 10.9 months in patients on placebo.

Non-urothelial tract recurrence-free survival (NUTRFS): NUTRFS measures the time patients lived outside the bladder, ureters, or renal pelvis without cancer recurrence. The NUTRFS was 25.9 months in patients on the Opdivo arm versus 13.7 months in patients on placebo.

Safety: Grade 3 adverse events were reported in 18.2% of patients, and grade 4 adverse events were reported in 7.2%.



Talzenna and Xtandi combination showed improvements in reducing the risk of disease progression in men with metastatic castration-resistant prostate cancer.

Pfizer presented the Phase 3 results of the Talzenna (talazoparib) plus Xtandi (enzalutamide) combination, showing improvement in overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer. The combination has reduced the risk of disease progression or death by 37%.

The median radiographic progression-free survival was not reached in the Talzenna arm versus 21.9 months in the placebo arm. A trend in the improvement in overall survival was observed in Talzenna plus Xtandi combination versus placebo plus Xtandi.

The safety profile was consistent with the existing safety profile of Talzenna and Xtandi.

Pfizer has submitted a supplemental new drug application for the approval of the combination.


Gilead presented the efficacy data of Trodelvy in hard-to-treat urothelial cancer patients.

Gilead presented strong efficacy data of Trodelvy (sacituzumab govitecan) in both platinum-ineligible and rapidly progressing post-platinum metastatic urothelial cancer patients.

In patients who have progressed following platinum-based chemotherapy and checkpoint inhibitor therapy, the median overall survival was 10.9 months. The overall response rate was 28%, and the median duration of response was 8.2 months.

In platinum-ineligible patients, the median overall survival was 13.5 months, ORR was 32%, and the median duration of response was 5.6 months. The progression-free survival was 5.6 months.

In patients whose urothelial cancer progressed after platinum-based chemotherapy, the overall survival was 12.8 months, ORR was 41%, and median PFS was 5.3 months.

The US FDA granted accelerated approval for Trodelvy to treat mUC patients previously treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitor.


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