Discover
Rubraca (rucaparib) / ClovisNew Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) - Sep 17, 2020 - P3, N=564; ARIEL3 (NCT01968213); Sponsor: Clovis Oncology, Inc; "After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm....The median duration of the first event of frequently reported TEAEs was generally Zejula (niraparib) / GSK, ZAI Lab, J&J, TakedaPhase 3 NORA data of ZEJULA (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian cancer (GlobeNewswire) - Sep 19, 2020 - P3, N=553; NORA (NCT03709316); Sponsor: Zai Lab (Shanghai) Co., Ltd; “Niraparib treatment resulted in a 68% reduction in the risk of disease progression or death in the overall population (PFS HR 0.32; 95% CI, 0.23–0.45; p Zejula (niraparib) / GSK, ZAI Lab, J&J, TakedaEuropean advisory group backs expanded use of Glaxo's Zejula (SeekingAlpha) - Sep 18, 2020 - "The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of GlaxoSmithKline's (GSK +0.0%) Zejula (niraparib) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemo." Rubraca (rucaparib) / ClovisRucaparib: “All patients in the rucaparib arm and 182/189 (96.3%) patients in the placebo arm experienced ≥1 TEAE“; Ovarian cancer (Clovis Oncology) - Sep 19, 2020 - ESMO 2020: "Grade ≥3 TEAEs were reported by 231/372 (62.1%) patients in the rucaparib arm and 31/189 (16.4%) patients in the placebo arm, Grade 4 TEAEs were reported by 28/372 (7.5%) and 2/189 patients (1.1%) in the rucaparib and placebo arms, respectively. The most frequent grade 4 TEAEs in the rucaparib arm were neutropenia/ decreased neutrophils and thrombocytopenia/decreased platelets (7/372 patients [1.9%] each)" [Screenshot] Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020 (Businesswire) - Sep 20, 2020 - P2, N=100; LEAP-004 (NCT03776136); Sponsor: Merck Sharp & Dohme Corp; P2, N=600; LEAP-005 (NCT03797326); Sponsor: Merck Sharp & Dohme Corp; “In the Phase 2 LEAP-004 trial, KEYTRUDA plus LENVIMA showed an objective response rate (ORR) of 21.4% (95% CI: 13.9-30.5) in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. In the Phase 2 LEAP-005 trial, KEYTRUDA plus LENVIMA demonstrated an ORR that ranged from 9.7-32.3% (95% CI: 2.0-51.4) in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (non-microsatellite instability-high [non-MSI-H]/mismatch repair proficient [pMMR]), glioblastoma multiforme (GBM) and biliary tract cancer (BTC).” Lynparza (olaparib) / Merck (MSD), AstraZenecaLYNPARZA (olaparib) Improved Median Progression-Free Survival to Over Four and a Half Years Compared to 13.8 Months with Placebo for Patients with BRCA-Mutated Advanced Ovarian Cancer (Businesswire) - Sep 18, 2020 - P3, N=450; SOLO-1 (NCT01844986); Sponsor: AstraZeneca; “Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI 0.25–0.43]), and improved median PFS to 56 months vs. 13.8 months for placebo. At five years, 48.3% of patients treated with LYNPARZA remained free from disease progression vs. 20.5% on placebo. The median duration of treatment with LYNPARZA was 24.6 months vs. 13.9 months with placebo. Median follow-up in the LYNPARZA arm was 4.8 years and 5 years for placebo. The safety profile of LYNPARZA was consistent with previous observations in SOLO-1. The most common adverse reactions (ARs) ≥20% were nausea (77%), fatigue/asthenia (63%), vomiting (40%), anemia (39%) and diarrhea (34%).” Imfinzi (durvalumab) / AstraZeneca; Zepzelca (lurbinectedin) / PharmaMar, Jazz; Opdivo (nivolumab) / Ono Pharma, BMSPharmaMar will present data for Zepzelca (lurbinectedin) and Yondelis (trabectedin) at ESMO 2020 (Pharmamar Press Release) - Sep 14, 2020 - “At the European Society of Medical Oncology (ESMO) Congress, which will be held virtually from 17th to 19th of September, PharmaMar (MSE:PHM) will present data on lurbinectedin in second-line SCLC patients who had received previous platinum-based chemotherapy and relapsed 90 and 180 days after its completion and therefore, being candidates for platinum rechallenge. Phase I results for lurbinectedin in Japanese patients with previously treated advanced Solid Tumours, will also be presented. Results of trabectedin in combination with immunotherapy (durvalumab) in pretreated patients with advanced Soft-Tissue Sarcomas, will be presented at an oral session. In addition, results of Yondelis® (trabectedin) in combination with immunotherapy (nivolumab) for the treatment of Soft-Tissue Sarcoma, as well as results of trabectedin in combination with doxorubicin (PLD) for the treatment of Recurrent Ovarian Cancer, will be presented.” Lynparza (olaparib) / Merck (MSD), AstraZeneca'OLAP' (OLAparib Regulatory Post-marketing Surveillance) (clinicaltrials.gov) - Sep 18, 2020 - P; N=600; Not yet recruiting; Sponsor: AstraZeneca Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSKGSK highlights scientific advances across its growing oncology portfolio at ESMO Virtual Congress 2020 (PRNewswire) - Sep 15, 2020 - "GSK presentations at ESMO will focus on research intended to improve outcomes for women with high unmet medical needs, including data related to the safety and efficacy of ZEJULA in patients with advanced, recurrent or resistant ovarian cancer. Investigators also will present a late-breaking presentation: 'Safety and Antitumor Activity of Dostarlimab in Patients (Pts) with Advanced or Recurrent DNA Mismatch Repair Deficient (dMMR) or Proficient (MMRp) Endometrial Cancer (EC): Results from GARNET.'" ALKS 4230 / Alkermes; Keytruda (pembrolizumab) / Merck (MSD)Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress (PRNewswire) - Sep 18, 2020 - P1/2, N=347; ARTISTRY-1 (NCT02799095); Sponsor: Alkermes, Inc; "Data presented at ESMO from the combination stage of ARTISTRY-1…Of these 5 patients: One patient with platinum-resistant ovarian cancer achieved a complete response (CR) by week 45 of treatment, and a deepening of response was observed through week 81 of treatment. As of the data cut, this patient had a durable, confirmed CR and had remained on treatment for more than 18 months. Two other patients with platinum-resistant ovarian cancer achieved PRs, one confirmed and one unconfirmed. As of the data cut, the patient with the confirmed PR demonstrated a deepening of response and had remained on treatment for more than 5 months. Other tumor types Additional PRs were achieved in multiple other tumor types across the PD-1/L1 approved and unapproved cohorts, including one patient with triple-negative breast cancer and two patients with esophageal cancer (one of which is awaiting confirmation)."
