On March 1, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported that the Spanish Drug Agency (Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS) has made available a new early access program that will allow access to Tedopi through a Special Situation Authorization(1) in the treatment of advanced or metastatic non-small cell lung (NSCLC) after immune checkpoint inhibitor (ICI) failure (Press release, OSE Immunotherapeutics, MAR 1, 2023, View Source [SID1234628019]). This Special Situation Authorization is based on the positive clinical data from the initial phase 3 trial of Tedopi (ATALANTE-1) in third line treatment and the high unmet need for these patients.

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Tedopi is the first cancer vaccine to show positive and clinically meaningful efficacy results with significant gain in survival associated with a better safety and quality of life profile in advanced NSCLC patients, administered in monotherapy versus active comparator (chemotherapy-based standard of care), in third line with secondary resistance to immune checkpoint inhibitor (ICI).

OSE Immunotherapeutics is committed to provide Tedopi through early access and compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement. Patients can benefit from Tedopi through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France and Italy.

In Spain, following the earlier nominative compassionate use program for patients that were included in the phase 3 ATALANTE-1 trial, the Health Authorities are now expecting applications for the early access to Tedopi through an unlimited Special Situation program, confirming thereby the significant medical need for new therapeutic alternatives in this patient population.

Dr. Santiago Viteri, investigator in ATALANTE-1 study and Medical Director of UOMI Cancer Center, Clinica Mi Tres Torres, Barcelona, comments:

"The decision of the Spanish Health Agency to approve Tedopi under a Special Situation Authorization for use will facilitate early access to treatment until Marketing Authorization and represent a significant benefit for patients in third line in secondary resistance post-sequential chemotherapy and immunotherapy. Indeed, there is a high unmet need for these patients as there are no therapeutic options yet approved after failure to immunotherapies and last resort chemotherapies are associated with multiple side effects and a poor quality of life."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "Following the positive recommendations from the US Food and Drug Administration (FDA) "Type C" meeting and the European Medicines Agency (EMA) scientific advice, OSE Immunotherapeutics is continuing the clinical development for Tedopi in second line treatment to support its regulatory registration in secondary resistance to immunotherapy. We are preparing a new confirmatory phase 3 clinical trial versus standard of care for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC)."

(1) The Special Situation Authorization (Real Decreto 1015/2009) is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorized therapeutic alternatives available.

On March 1, 2023 Novocure (NASDAQ:NVCR) reported the reimbursement and availability of Optune together with temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM) in France (Press release, NovoCure, MAR 1, 2023, View Source [SID1234628018]). The order registering Optune on the List of Reimbursable Products and Services (LPPR) provided for in Article L165-1 of the Social Security Code was published in the Official Journal on February 28, 2023 and will become effective March 15, 2023.

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"We are pleased to make Optune available to French patients and healthcare professionals for the treatment of glioblastoma," said Anne Calixte de Lembeye, General Manager of Novocure France. "GBM is one of the most common and most aggressive forms of primary brain cancer with a poor prognosis. We are energized and prepared to support patients in France as they begin to use our therapy as an additional treatment choice for newly diagnosed GBM."

Optune is a medical device that works by creating Tumor Treating Fields (TTFields), which are electric fields that disrupt cancer cell division. Optune delivers TTFields therapy to the region of the tumor. Optune is small and light, weighing 2.7 pounds. This makes Optune wearable and portable, so continuous treatment can be received almost anywhere. Globally, more than 27,000 patients have been treated with Optune, to date.

The favorable opinion of the CNEDIMTS (Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé) was obtained on July 20, 2021. It highlights a sufficient expected service and a level III expected service improvement (ASA) for the use of Optune in combination with TMZ after surgery and radio-chemotherapy in adult patients with newly diagnosed GBM.

Novocure’s phase 3 pivotal EF-14 study compared Optune plus TMZ to TMZ alone in 695 patients with newly diagnosed GBM1. Median progression-free survival from randomization was 6.7 months in the TTFields-TMZ group and 4.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-TMZ group versus 16.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Optune was used together with TMZ with no significant increase in serious adverse events compared with TMZ alone. The most common side effect related to Optune alone was mild to moderate skin irritation.

Optune has the CE mark and is commercially available as a treatment for GBM in multiple countries in North America, Europe and Asia. In addition to France, Optune is reimbursed in Austria, Germany, Israel, Japan, Sweden, Switzerland and the United States.

"At Novocure, we feel a daily responsibility to bring our therapy to as many patients who can benefit throughout the world," said Novocure CEO Asaf Danziger. "We are proud that Optune is now a treatment choice for newly diagnosed GBM patients in France. We look forward to supporting patients and physicians in France as they begin to use our therapy, and continue to work diligently to bring our therapy to patients in additional markets."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

Tumor Treating Fields therapy uses electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields therapy is approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On March 1, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the 43rd Annual Cowen Healthcare Conference on Wednesday, March 8, 2023, at 9:10 a.m. ET in Boston (Press release, Nuvalent, MAR 1, 2023, View Source [SID1234628016]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On March 1, 2023 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, reported that European Medicine Agency (EMA) approved the phase Ib/II study of GFH925 (KRASG12C inhibitor) in combination with ERBITUX (cetuximab) (Press release, GenFleet Therapeutics, MAR 1, 2023, View Source [SID1234628015]). This is the first therapy combining a KRASG12C inhibitor and cetuximab granted with CTA approval to treat advanced patients with KRASG12C-mutant NSCLC (non-small cell lung cancer) in the first-line setting.

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With study concept proposed by GenFleet, the trial is led by Professor Rafael Rosell, a world-renowned expert in particular in the field of lung cancer, with scores of clinical research centers participating in the study across Europe. GenFleet will firstly initiate the overseas study, followed by domestic trials conducted by its partner Innovent Biologics, to accelerate the clinical development of the combination therapy treating NSCLC in first-line setting.

"GFH925 is an investigational product with promising efficacy and good safety profile as monotherapy developed by Chinese biotech. This product has been granted breakthrough therapy designation (BTD) by NMPA in China. The innovative and thoughtful idea of combining GFH925 with Erbitux will potentially pave the way for bringing KRAS inhibitors to treat NSCLC in the first-line setting. The study is among the few combination trials that target the frontline treatment and is in leading position when compared with other pharmaceutical companies. We look forward to seeing data from this study." said Professor Rafael Rosell, Quiron-Dexeus University Institute and Catalan Institute of Oncology.

"As GenFleet’s first multi-center study in Europe, it highlights our ability for novel design and our efficiency executing cross-border combination trials. Currently, GenFleet and our partner are conducting a number of trials in different regions across the globe, demonstrating the broad prospects of GFH925 in clinical development. Through collaboration with our industry-leading partners, we hope innovative therapies can be delivered fast to benefit patients worldwide. " said by Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

About GFH925X0201 and GFH925

The multi-center study of GFH925 in combination with cetuximab is to kick off in scores of clinical rsearch centers worldwide and sets its objectives to evaluate the safety/tolerance, efficacy and the pharmacokinetic characteristics of the combination in advanced NSCLC patients harboring KRASG12C mutation.

The phase I data of GFH925 monotherapy were presented at ASCO (Free ASCO Whitepaper) and CSCO annual meetings in 2022. Of 21 patients with NSCLC treated at 600mg BID (the recommended phase 2 dose), better efficacy signal was observed, with investigator assessed ORR 61.9% and DCR 100%. GFH925 monotherapy has been granted with breakthrough therapy designation by CDE, to treat advanced NSCLC patients with KRASG12C mutation that have received at least one prior line of systemic therapy.

By covalently and irreversibly modifying the cysteine residue of KRASG12C protein, GFH925 inhibits the GTP/GDP exchange, an essential step in pathway activation. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites.

On March 1, 2023 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) (Press release, Janssen Biotech, MAR 1, 2023, View Source [SID1234628014]). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alteration.

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"Patients with mCRPC and BRCA mutations face a more aggressive form of prostate cancer and high unmet needs in terms of treatment options. The data supporting this submission reinforce the importance of biomarker testing to identify the subgroups of patients that are most likely to respond to a targeted treatment option," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This submission further represents our commitment at Janssen to discover and develop precision medicine approaches and combination therapies to help improve outcomes for patients living with genetically defined disease."

Prostate cancer is one of the most common cancers in the U.S., with an estimated 268,490 new cases diagnosed in 2022.1 Approximately 10 to 50 percent of patients progress to mCRPC within three years of diagnosis,2 of which an estimated 10 to 15 percent harbor a BRCA mutation.3,4

The combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a prodrug of abiraterone, a CYP17 inhibitor, plus prednisone, targets two oncogenic drivers in patients with mCRPC: the androgen receptor axis and HRR gene alterations. The combination of niraparib with abiraterone acetate plus prednisone (AAP) is intended for patients with BRCA mutations who have not received prior treatment for mCRPC except for standard of care, next-generation androgen receptor inhibitors and up to four months of AAP. Through the DAT formulation, this therapeutic option may help improve compliance and reduce pill burden.

The NDA is supported by data from the MAGNITUDE study (NCT03748641), a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of niraparib plus AAP as a first-line treatment in patients with mCRPC, with or without alterations in HRR associated genes.1 Patients with HRR gene alterations were randomized to receive niraparib 200 mg once daily plus AAP [n=212], or placebo plus AAP [n=211].

First results from MAGNITUDE were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Genitourinary Cancers Symposium (ASCO GU) 2022 Annual Meeting (Abstract #12) for the primary endpoint of investigator-evaluated radiographic progression-free survival (rPFS) in all HRR-positive patients, as well as patients with BRCA mutations, receiving niraparib plus AAP.5 Results from the secondary interim analysis (IA2) were presented at the ASCO (Free ASCO Whitepaper) GU 2023 Annual Meeting (Abstract #170). In IA2, at 26.8 months of median follow-up, researchers further reviewed time to symptomatic progression (TSP) and time-to-initiation of cytotoxic chemotherapy (TCC) in the HRR-positive population and the BRCA subgroup.

The study continues to collect data on the secondary endpoints, which include TCC, TSP and overall survival.

About niraparib
Niraparib is an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.

Additional ongoing studies include the Phase 3 AMPLITUDE study, evaluating the combination of niraparib and AAP in a biomarker-selected patient population with metastatic castration-sensitive prostate cancer (mCSPC).6

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer.

In the United States, niraparib is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy; and for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Niraparib is currently marketed by GSK as ZEJULA.7

In April 2022, Janssen submitted a marketing authorisation application to the European Medicines Agency seeking approval for niraparib in combination with abiraterone acetate in the form of a DAT, plus prednisone or prednisolone, based on data from the MAGNITUDE study. Marketing authorisation applications are under review across a number of countries globally.

On February 24, 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for niraparib in combination with abiraterone acetate in the form of a DAT, plus prednisone or prednisolone, for the treatment of adult patients with mCRPC and BRCA mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

About metastatic castration-resistant prostate cancer
Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to androgen deprivation therapy and has spread to other parts of the body. The most common metastatic sites are bones, followed by lungs and liver.8 Prostate cancer is the second most common cancer in men worldwide, behind lung cancer.3 More than one million patients around the world are diagnosed with prostate cancer each year.9 Patients with mCRPC and HRR gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time.2,3,4,5

About MAGNITUDE
MAGNITUDE (NCT03748641) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the safety and efficacy of the combination of niraparib and AAP for patients with mCRPC, with or without certain HRR gene alterations, and who have not received prior therapy for mCRPC except for standard of care, next-generation androgen receptor inhibitors and up to four months of AAP. Patients were randomized to receive either niraparib and AAP or placebo and AAP. Additionally in an open-label cohort of HRR-positive patients, all patients received the DAT formulation of niraparib and abiraterone acetate plus prednisone.2 The primary endpoint of the MAGNITUDE trial is rPFS determined by blinded independent central review. Secondary endpoints include TCC, TSP and overall survival.2

About abiraterone acetate
Abiraterone acetate is an orally administered androgen biosynthesis inhibitor. In the United States, abiraterone acetate is indicated with prednisone for the treatment of mCRPC and high-risk mCSPC.