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European Society for Medical Oncology Congress 2023| Genitourinary cancers | Updates| iPharmaCenter

Updated: Oct 27, 2023

October 22, 2023

Tivdak Reveals Overall Survival Benefit Over Chemotherapy in Metastatic Cervical Cancer Patients


Seagen has unveiled the results of the Phase 3 innovaTV 301 trial, showcasing the effectiveness of Tivdak (tisotumab vedotin) in treating patients with metastatic cervical cancer. Tivdak has demonstrated significant improvements in overall survival, progression-free survival, and objective response rates when compared to chemotherapy. The trial included patients whose disease progressed following first-line therapy.


The study revealed a 30% reduction in the risk of disease progression or death when patients were treated with Tivdak compared to chemotherapy.

Furthermore, there was a 33% reduction in the risk of disease worsening or death, highlighting a substantial enhancement in progression-free survival. Notably, the confirmed response rate stood at 17.8% for the Tivdak group, while only 5.2% of patients on chemotherapy achieved the same response.


The safety profile of Tivdak remained consistent with the established adverse events profile of the treatment.

 

October 22, 2023

Keytruda and Padcev Combination Shows Promising Results in First-Line Treatment for Advanced Bladder Cancer


Seagen has presented encouraging data regarding the combination of Keytruda and Padcev as first-line therapy for advanced bladder cancer patients. The Phase 3 EV-302 clinical trial results show the effectiveness of this combination in treating advanced bladder cancer.

Patients on the Keytruda plus Padcev combination exhibited a median overall survival of 31.5 months, a stark contrast to the 16.1 months observed in patients receiving chemotherapy. Similarly, the median progression-free survival for the Keytruda plus Padcev group was 12.5 months, while patients on chemotherapy had a median PFS of 6.3 months.


Furthermore, the objective response rate was notably higher for patients on the Padcev combination, reaching 68%, compared to the 44% response rate observed in patients on chemotherapy. Among these responders, 29.1% achieved a complete response, while in the chemotherapy group, only 12.5% achieved the same. It's worth mentioning that the median duration of response was not reached in the Padcev combination group, whereas patients on chemotherapy had a median response duration of 7 months.

Seagen has plans to submit the Phase 3 EV-302 trial for approval to global regulatory agencies, showcasing their commitment to advancing treatment options for advanced bladder cancer patients.


 

October 22, 2023

Positive OS Findings from Phase 3 MAGNITUDE Study in mCRPC Patients with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone


Janssen Pharmaceutical presented the final results of the Phase 3 MAGNITUDE study, shedding light on promising trends in patient outcomes. The study focused on patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) presenting BRCA alterations, who were treated with niraparib, abiraterone acetate, and prednisone.

The final multivariate analysis (MVA) of the Phase 3 MAGNITUDE study revealed significant insights.


The data, obtained after a median follow-up of 35.9 months, displayed encouraging findings. The analysis demonstrated an overall survival (OS) benefit for patients receiving niraparib plus AAP compared to those in the placebo plus AAP arm. The improvement in time to symptomatic progression (TSP) continued to show promise in patients treated with niraparib and AAP.



Of particular note, a significant proportion of patients in the niraparib and AAP group (70 percent) subsequently received life-prolonging therapy, in contrast to 86 percent of patients who received a placebo.


The analysis also included patient-reported outcomes, which unveiled a promising trend toward delayed time to worst pain progression and pain interference progression in patients with BRCA mutations administered with niraparib and AAP compared to the placebo group.


Importantly, the final analysis did not identify any new safety concerns, and no cases of myelodysplastic syndrome or acute myeloid leukemia were observed among patients in the niraparib and AAP group. However, it's noteworthy that the niraparib plus AAP treatment exhibited higher rates of adverse events (AEs) of special interest compared to the placebo group.

 

October 21, 2023

Promising Results from Phase 2 THOR-2 Study: Janssen's Balversa Enhances Recurrence-Free Survival in High-Risk Bladder Cancer


New data from the Phase 2 THOR-2 study conducted by Jassen Pharmaceuticals reveal promising results in treating high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with specific fibroblast growth factor receptor (FGFR) alterations. Patients who had previously experienced recurrences after Bacillus Calmette-Guérin (BCG) therapy were enrolled in the study. In Cohort 1 of the trial involving 73 patients, 49 were assigned to receive Balversa (erdafitinib), while 24 were given intravesical chemotherapy, representing the investigator's choice.


The findings are significant as oral Balversa (erdafitinib) reduced the risk of disease recurrence or death by a substantial 72% compared to intravesical chemotherapy in patients with high-risk resected papillary Ta/T1 NMIBC carrying FGFR mutations or fusions, who had experienced a recurrence after BCG therapy or were not suitable for radical cystectomy.


With a median follow-up period of 13.4 months, the median recurrence-free survival (RFS) for patients who received Balversa was not reached. In contrast, the RFS for patients who received chemotherapy was 11.6 months. This indicates that Balversa has a significant impact on RFS.


Notably, the six-month RFS for patients on Balversa was an impressive 96%, whereas it was 73% for those who received chemotherapy. At the twelve-month mark, the RFS was 77% for patients who received Balversa, compared to just 41% for those who underwent chemotherapy.


The study reported grade 3 or 4 treatment-related severe adverse events (TRAEs) in 31% of patients who received Balversa and 4% of patients assigned to chemotherapy.

 

October 21, 2023

AstraZeneca's new data shows Imfinzi plus Lynparza combination significantly reduces disease progression in patients with endometrial cancer.


AstraZeneca presented the positive results of the DUO-E Phase III study, revealing the efficacy of combining Imfinzi (durvalumab) with platinum-based chemotherapy in treating advanced or recurrent endometrial cancer. This approach, followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib), has significantly reduced disease progression or death risk compared to chemotherapy alone, marking the first Phase III trial to demonstrate the clinical benefits of immunotherapy combined with PARP inhibition in this context.



In the overall trial population, the data indicate that both treatment strategies, Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza and Imfinzi plus chemotherapy followed by Imfinzi monotherapy, have substantially reduced the risk of disease progression or death by 45% and 29%, respectively, compared to chemotherapy alone. Median progression-free survival (PFS) was notably prolonged, with 15.1 months in the Imfinzi plus Lynparza group and 9.6 months in the chemotherapy-only group.


PD-L1, a well-known biomarker for Imfinzi in other indications, was also assessed. The prespecified analysis based on PD-L1 status revealed that in the PD-L1 positive population, both Imfinzi plus Lynparza and Imfinzi monotherapy reduced the risk of disease progression or death by 58% and 37%, respectively, compared to the chemotherapy-only approach. Median PFS was extended to 20.8 months in the Imfinzi plus Lynparza group, while it was 9.5 months in the control group.



For the PD-L1 negative population, reductions of 20% and 11% in the risk of disease progression or death were observed in the Imfinzi plus Lynparza and Imfinzi monotherapy groups, respectively, compared to the control arm.


Both regimens' safety and tolerability profiles (Imfinzi plus Lynparza and Imfinzi monotherapy) were in-line with the established safety profile in the previous clinical trials. AstraZeneca stated that these findings significantly help to treat advanced or recurrent endometrial cancer.



 

October 20, 2023

Merck presented positive data on Keytruda as first-line therapy for cervical cancer

Merck shared the results from the significant Phase 3 KEYNOTE-A18 trial, which explored the use of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) and concurrent chemotherapy, followed by brachytherapy (also referred to as concurrent chemoradiotherapy). This trial was designed for newly diagnosed patients facing high-risk locally advanced cervical cancer, encompassing stage 1B2-2B with lymph node-positive disease and stage 3-4A with or without lymph node-positive disease.


The findings from this study reveal that including Keytruda alongside concurrent chemoradiotherapy significantly improved progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients.


Following a median follow-up of 17.9 months (ranging from 0.9 to 31.0 months), the Keytruda regimen reduced the risk of disease progression or death by 30%. The 24-month PFS rate also showed a notable increase, with 67.8% for patients receiving the Keytruda regimen versus 57.3% for those solely receiving concurrent chemoradiotherapy. In addition to the improvements in PFS, there was a promising trend in overall survival (OS), another primary endpoint of the trial.


The safety profile of Keytruda observed in this trial remained consistent with previous studies, with no new safety concerns identified.




 

BMS presented Opdivo data in urothelial carcinoma patients as first-line treatment.


Bristol Myers Squibb has presented the initial findings from the Phase 3 CheckMate -901 trial, which focused on treating unresectable or metastatic urothelial carcinoma in cisplatin-eligible patients. In this trial, Opdivo (nivolumab), administered in combination with cisplatin-based chemotherapy, followed by Opdivo monotherapy, has demonstrated clinically significant advancements in the primary efficacy parameters of overall survival (OS) and progression-free survival (PFS). This combination therapy has exhibited notable benefits compared to the standard-of-care cisplatin-based chemotherapy in the first-line treatment of this patient cohort.


Patients who received the Opdivo and cisplatin-based chemotherapy combination achieved a remarkable 22% reduction in mortality risk after a median follow-up of 33 months.


The summary of the results is as follows:

Opdivo + Chemotherapy

Chemotherapy

Overall Survival (OS)

Median OS

21.7 months

18.9 months

12-Month OS

70.2%

62.7%

24-Month OS

46.9%

40.7%

Progression-Free Survival (PFS)

Median PFS

7.9 months

7.6 months

12-Month PFS Rate

34.2%

21.8%

24-Month PFS Rate

23.5%

9.6%

Objective Response Rate (ORR)

57.6%

43.1%

Complete Response (CR)

21.7%

11.8%

Duration of Complete Response

37.1 months

13.2 months

Notably, the combination of Opdivo with cisplatin-based chemotherapy demonstrated a well-tolerated safety profile in accordance with the known safety profiles of the individual components of the regimen.




 


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