Roche's Phase III IMagyn050 Trial of Tecentriq Plus Avastin and Chemotherapy Fails to Improve Progression-Free Survival in First-Line Advanced Ovarian Cancer

July 13, 2020 /Bio ValleyBIOON/ -- Roche recently announced the first-line treatment of newDiagnosisLatest Advances in the Phase III IMagyn050 Study in Women with Advanced Ovarian Cancer. The results showed that adding Tecentriq to the combination regimen of Avastin (bevacizumab), paclitaxel, and carboplatin failed to meet the primary endpoint of improving progression-free survival (PFS).

IMagyn050 is a multicenter, randomized, double-blind Phase III study conducted in patients with Stage III or IV ovarian cancer receiving neoadjuvant or adjuvant therapy, to evaluate the efficacy and safety of the combination regimen of Tecentriq + Avastin + paclitaxel + carboplatin versus Avastin + paclitaxel + carboplatin. In the study, patients were randomized in a 1:1 ratio either before tumor resection surgery (neoadjuvant) or after surgery (adjuvant). The co-primary endpoints were progression-free survival (PFS) and overall survival (OS), as determined by the study investigators, in both the intent-to-treat (ITT) population and the PD-L1-positive subgroup. Key secondary endpoints included objective response rate (ORR), safety, tolerability, and improvements in patient-reported abdominal pain and bloating. The study is being conducted by Roche in collaboration with the GOG Foundation, Inc. (GOG Foundation) [GOG-3015] and the European GynecologicalTumorConducted in collaboration with the Experimental Gynecologic Oncology Group Network (ENGOT) [ENGOT OV-39].

The released data showed that, compared with the combination regimen of Avastin plus paclitaxel and carboplatin, the combination regimen of Tecentriq plus Avastin, paclitaxel, and carboplatin did not improve progression-free survival (PFS). In this study, the safety profile of Tecentriq in combination with Avastin, paclitaxel, and carboplatin was consistent with the known safety profile of the combination therapy.

Currently, the data for the co-primary endpoint of overall survival (OS) in this study are not yet mature, and follow-up will continue until the next planned analysis. The results of the IMagyn050 study will be further evaluated to inform the Tecentriq gynecologic development program. The Tecentriq ovarian cancer and cervical cancer programs build upon the combination of Tecentriq and Avastin, a regimen that can help newDiagnosisWomen with advanced or recurrent ovarian and cervical cancer live longer without disease progression, a finding demonstrated in seven pivotal Phase III trials involving more than 5,000 women.

Roche has developed an extensive development program for Tecentriq, including multiple ongoing and planned studies in lung cancer, genitourinary cancers, skin cancer,Breast Cancer, Phase III studies in gastrointestinal cancers, gynecologic cancers, and head and neck cancers, including evaluations of Tecentriq as monotherapy or in combination with other agents.

Dr. Levi Garraway, Chief Medical Officer and Global Head of Product Development at Roche, stated, “Ovarian cancer remains one of the most aggressive cancers, with advanced-stage disease being difficult to treat. Nevertheless, we remain committed to improving outcomes for women with this disease and are pleased that Avastin continues to be a key component of first-line treatment regimens for ovarian cancer.”

Ovarian cancer is the eighth most common cancer among women worldwide, with nearly 300,000 new cases each year.DiagnosisCase. Ovarian cancer remains a malignantTumorThe primary cause of death, as most patients are not diagnosed until the disease has reached an advanced stageDiagnosis, with a 5-year survival rate of less than 30%.

Tecentriq is a PD-(L)1 tumor immunotherapy that targets and binds to tumor cells andTumorPD-L1 protein expressed on infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq can activate T cells. To date, Tecentriq has been approved in multiple countries as monotherapy and in combination with targeted therapy and/or chemotherapy for the treatment of various types of cancer, including: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma (mUC), and PD-L1-positive triple-negative breast cancer (TNBC).

Avastin is an angiogenesis inhibitor that targets and binds to vascular endothelial growth factor (VEGF). VEGF plays a crucial role in angiogenesis and maintenance during the tumor life cycle. Avastin disrupts the tumor's blood supply by directly binding to VEGF, thereby preventing its interaction with receptors on endothelial cells. The tumor's blood supply is consideredTumorThe key to in vivo growth and metastatic capacity.

There is a strong scientific rationale for the combination of Tecentriq and Avastin, as the Tecentriq plus Avastin regimen has the potential to enhance the immune system’s ability to combat tumors. In addition to its established anti-angiogenic effects, Avastin can also inhibit VEGF-mediated immunosuppression, promote T-cell infiltration into tumors, and prime T cells againstTumorantigen response, further enhancing Tecentriq’s ability to restore the body’s anti-cancer immunity.

In the United States,FDAApproved in December 2018 for the first-line treatment of patients without EGFR or ALK genomic alterations using Tecentriq + Avastin + chemotherapy (carboplatin and paclitaxel)TumorAdult patients with metastatic non-squamous non-small cell lung cancer (NSq NSCLC) harboring alterations. This approval is based on data from Cohort B of the IMpower150 study: in intention-to-treat wild-type (ITT-WT) patients, Tecentriq plus Avastin plus chemotherapy significantly prolonged overall survival compared with Avastin plus chemotherapy (median OS: 19.2 months vs. 14.7 months; HR=0.78; p=0.016).

At the end of May this year,FDAApproval of Tecentriq + Avastin for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy. Notably, the Tecentriq + Avastin combination is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic HCC. From IMbrave150Clinical TrialData show that, compared with the standard-of-care drug sorafenib, the combination of Tecentriq and Avastin significantly prolonged overall survival (OS) and progression-free survival (PFS). (Bioon.com)

Original Source:Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer