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Category: Cancer

BioNTech to Present Data from BNT311 (GEN1046) and BNT131 (SAR441000) Programs at SITC 35th Annual Meeting

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that results from three clinical and preclinical studies have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting. The data represent the first clinical results from BioNTech’s ongoing collaborations with Genmab and Sanofi from both its mRNA and antibody […]

Bayer and Systems Oncology sign exclusive license agreement on innovative breast cancer treatment approach ERSO™

Bayer has entered into an exclusive global license agreement with Systems Oncology, LLC, for ERSO™, a compound in pre-clinical development for the treatment of metastatic Estrogen Receptor-positive (ER+) breast cancer. ERSO is a small molecule activator of the Unfolded Protein Response (UPR) in ER+ breast cancer cells. ERSO’s differentiated mechanism of action offers significant potential […]

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

• Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours. • Blueprint Medicines and Roche will collaborate on the development of pralsetinib. • Roche and Blueprint Medicines will co-commercialise pralsetinib in […]

Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III IPATential150 study met its co-primary […]

Roche’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response

…. regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer • IMpassion031 data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency • Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very […]

Positive phase III results for Venclexta/Venclyxto combination in acute myeloid leukaemia presented at EHA 2020

• Phase III VIALE-A study showed Venclexta/Venclyxto plus azacitidine helped people with the most common type of aggressive adult leukaemia live longer compared to azacitidine alone • Data will be presented as a late-breaking abstract at the 25th European Hematology Association Virtual Congress Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the […]

FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

• Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma • Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care • Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme Roche […]

Updated data demonstrate Roche’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer

• ALEX study is the first global phase III study to show a clinically meaningful benefit in overall survival at five years (62.5% with Alecensa), compared with crizotinib (45.5%) • Data confirm longer-term efficacy of Alecensa, both in patients with or without central nervous system metastases at baseline Roche (SIX: RO, ROG; OTCQX: RHHBY) on […]

CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours

…..and for people with ROS1-positive, advanced non-small cell lung cancer •Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche’s first tumour-agnostic therapy in Europe Roche (SIX: RO, ROG; OTCQX: RHHBY) announced on May 29th, 2020 that the European Medicines Agency’s (EMA) Committee for […]

Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

• Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in Europe • Phase III trial showed Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in this patient population, compared to fulvestrant alone • PIK3CA mutations affect […]

Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery

• More than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1 • Study conclusions are drawn from the largest dataset and longest follow-up to date of patients with BRAF-mutated melanoma treated with targeted therapy following the surgical removal of their cancer1,2 • Data […]

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne CDx (Foundation Medicine, […]

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ […]

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma […]

FDA approves ripretinib for advanced gastrointestinal stromal tumor

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with […]