On September 6, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from its broad clinical development programme across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC), taking place from 23–26 September in Toronto, Canada (Press release, Hoffmann-La Roche, SEP 6, 2018, View Source [SID1234529353]). 10 abstracts have been accepted, including three ‘late breakers’ and five oral presentations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to presenting new data from our comprehensive lung cancer programme, including new immunotherapy and targeted treatment strategies across different types of lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are particularly pleased to be sharing positive TECENTRIQ data in extensive-stage small cell lung cancer, which has seen limited progress in treatment over the last two decades, as well as new pivotal data for our investigational therapy entrectinib for the treatment of ROS1 fusion-positive lung cancer."

Key presentations
Progression-free survival (PFS) and overall survival (OS) data from the Phase III IMpower133 study of TECENTRIQ plus chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC) will be presented in the Presidential Symposium. These are the first positive survival data from a Phase III study with an immunotherapy-based combination in the initial treatment of ES-SCLC.

PFS and OS data will be presented from the Phase III IMpower132 study investigating TECENTRIQ plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) in the initial treatment of people with advanced non-squamous NSCLC. The IMpower132 and IMpower133 data will be featured as part of WCLC’s official press programme on Monday 24th and Tuesday 25th of September, respectively.

Additionally, results from a Phase Ib study investigating Tarceva plus TECENTRIQ in tyrosine kinase inhibitor (TKI)-naïve people with EGFR mutation-positive NSCLC will also be presented.

New pivotal results of entrectinib, an investigational oral, CNS-active treatment for people with locally advanced or metastatic ROS1 fusion-positive NSCLC, from a pooled analysis including the global Phase II STARTRK-2 basket study will be presented. These data have also been selected to be featured in the WCLC press programme on Monday 24th of September.

Follow Roche on Twitter via @Roche and keep up to date with WCLC 2018 congress news and updates by using the hashtag #WCLC2018.

For more information on Roche’s approach to cancer, visit Roche.com.

Overview of key presentations featuring Roche medicines at WCLC 2018

About NSCLC and SCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85% of all cases,2 with SCLC accounting for approximately 15% of all lung cancer cases.2 Survival rates for people with SCLC vary depending on the stage (extent) of the cancer at the time of diagnosis.3 The five-year relative survival rate for people with stage I SCLC is approximately 31%, however, at stage IV, the five-year relative survival rate declines to approximately 2%.4

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About ROS1 fusion-positive non-small cell lung cancer (NSCLC)
ROS1 is a tyrosine kinase, which play a role in controlling how cells grow and proliferate. When a ROS1 gene fusion occurs, ‘healthy’ cell signalling malfunctions, causing cells to grow and proliferate in an uncontrolled manner – this results in cancer.

ROS1 gene fusions account for 1-2% of NSCLC. Lung cancer is the leading cause of cancer-related death across the world. Each year, 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.1 NSCLC is the most prevalent type of lung cancer, accounting for around 85% of all cases.2 While the ROS1 gene fusion can be found in any patient with NSCLC, young never-smokers with NSCLC have the highest incidence of ROS1 fusions.

About entrectinib
Entrectinib (RXDX-101) is an investigational, oral medicine in development for the treatment of locally advanced or metastatic solid tumours that harbour NTRK1/2/3 or ROS1 fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK fusions. Entrectinib is being investigated across a range of solid tumour types, including NSCLC, pancreatic cancer, sarcomas, thyroid cancer, salivary cancer, gastrointestinal stromal tumours (GIST) and cancers of unknown primary (CUP).

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake designation by the Japanese health authorities for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

On August 6, 2018 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported that Manuel Aivado, MD, PhD, has been named President and Chief Executive Officer and elected to its Board of Directors (Press release, Aileron Therapeutics, SEPT 6, 2018, View Source;p=irol-newsArticle&ID=2366358 [SID1234529414]). Since 2012, Dr. Aivado has served as Aileron’s Senior Vice President and Chief Medical and Scientific Officer. He succeeds John P. Longenecker, PhD, who was appointed interim CEO on May 15, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to announce this well-deserved promotion for Dr. Aivado," said Aileron Chairman Jeff Bailey. "Manuel clearly best exemplifies the skill set and talent needed to lead the company through its next stage of development."

"I am very excited to take on this new responsibility at Aileron as we further expand the clinical development of our lead product candidate, ALRN-6924, into combination therapies. ALRN-6924 represents the proof-of-concept for Aileron’s stapled peptide technology, which I believe to be capable of producing additional novel drug candidates that address previously undruggable targets," said Dr. Aivado. "In the future, we plan to broaden the applicability of our technology and expand our external collaborations. I am pleased with the external recognition that ALRN-6924 and our stapled peptide technology have earned in the scientific community, and I look forward to additional collaborations translating this recognition into therapeutic and commercial success."

Dr. Aivado brings more than 20 years of scientific, medical, and executive leadership to this position. Most recently, Dr. Aivado led Aileron’s clinical testing of stapled peptides against intracellular targets and designed and implemented the ALRN-6924 first-in-human trial. ALRN-6924 was selected for the "Best of ASCO (Free ASCO Whitepaper) Meetings," which highlights the most cutting-edge science and education from the world’s premier oncology event. Prior to joining Aileron, Dr. Aivado served as Vice President of Clinical Development and Pharmacovigilance at Taiho Oncology, Inc. He previously served as a Senior Medical Director in clinical development at GlaxoSmithKline. In addition, Dr. Aivado was an Instructor in Medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for nearly ten years, during which he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician in internal medicine, hematology and medical oncology. He received his MD and PhD degrees from the Medical School of the University of Dusseldorf, Germany.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild-type p53 tumor suppression by disrupting the interactions between p53 and its two primary suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, the Company believes there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

On September 6, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for its lead product candidate, RP1, for patients with solid tumors (Press release, Replimune, SEP 6, 2018, View Source [SID1234529738]). The Company intends to open its ongoing Phase 1/2 clinical trial in the U.S. and begin enrolling patients in the fourth quarter of 2018. The clinical trial is currently ongoing in the U.K., as previously announced.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In part one of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors. Following this dose escalation phase, further patients will receive RP1 in combination with nivolumab anti-PD1 therapy. In part two of the Phase 1/2 clinical trial, expected to initiate in the first half of 2019, Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancers, and non-melanoma skin cancers. For each of the tumor types other than melanoma, patients will be naïve to immune checkpoint blockade, whereas in melanoma, patients both previously treated and previously untreated with immune checkpoint blockade will be enrolled. This clinical trial is a collaboration with Bristol Myers Squibb, which is providing nivolumab for use in the study.

RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency. This is intended to result in highly immunogenic cell death and robust activation of a systemic anti-tumor immune response.

About Oncolytic Immunotherapy
Oncolytic immunotherapy is an emerging class of cancer therapy which exploits the ability of viruses to selectively replicate in and kill tumors, while at the same time inducing a potent, patient-specific, anti-tumor immune response. Oncolytic viruses have the ability to induce a robust immune response against a patient’s particular complement of tumor antigens, including neo-antigens, in situ in the patient in an off-the-shelf format. While clinically active alone, oncolytic immunotherapy may have synergy with certain other treatments and, in particular, with immune checkpoint blockade therapies.

On September 6, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), reported its consolidated half-year financial results as of June 30, 2018 and provided an update on the key milestones reached during the 2018 first semester (Press release, OSE Immunotherapeutics, SEP 6, 2018, View Source [SID1234529338]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the completion of our license and collaboration agreement with Boehringer Ingelheim for OSE-172 in April, the first half 2018 marks an important second phase of growth for the Company, supported financially by our strategic partnerships and accompanied by a strengthened management team. Of significant note, the Company generated a financial profit of 8.9 million euros, which is a remarkable financial achievement for OSE," commented Alexis Peyroles, CEO of OSE Immunotherapeutics.

"We are focused on making significant clinical progress with four of our products, including three with our pharmaceutical partners: the initiation of a Phase 1/2 study of OSE-172 and a Phase 1 study of OSE-127 and the preparation of the entry into Phase 2 study with FR104. Furthermore, we were very pleased to receive the approval from the FDA and the EMA to actively advance the Tedopi Phase 3 trial in advanced non-small cell lung cancer in patients with immune escape after checkpoint inhibitors, a population for which no approved treatment is currently available. We also plan to start a Phase 2 trial of Tedopi combination therapy in pancreatic cancer by the end of 2018, a trial sponsored by the oncology group GERCOR. In the long term, our R&D teams are conducting innovative research to identify key targets of interest and develop new antibodies as candidates for clinical development in immuno-oncology," Mr. Peyroles continued.

Key First-Half 2018 Achievements

OSE-172, SIRPa antagonist and checkpoint inhibitor targeting suppressive myeloid/macrophage cells, in various solid tumors

Entered a global license and collaboration agreement with Boehringer Ingelheim to develop OSE-172. Under the terms of the agreement, OSE Immunotherapeutics has received a €15 million upfront payment from Boehringer Ingelheim, and will receive potential additional short-term milestones of up to €15 million upon initiation of a phase 1 clinical study. OSE Immunotherapeutics stands to receive more than €1.1 billion upon reaching pre-specified development, registration and sales milestones, plus royalties on worldwide net sales (cf. press release of April 4, 2018).
Expected to initiate clinical phase by the end of 2018, with potential application in various solid tumors, in partnership with Boehringer Ingelheim.
Tedopi, combination of optimized neoepitopes that induce specific T lymphocyte activation in immuno-oncology, in advanced lung cancer

Progressed an ongoing Phase 3 trial in patients with advanced and metastatic non-small cell lung cancer (NSCLC) who have failed a previous treatment with immune checkpoint inhibitors in Europe and in the U.S. Received approval from Israeli competent authorities to expand enrolment of the trial in this additional country.
Received a €435,000 grant from Bpifrance through the Eurostars European Programme to lead a research program within a consortium of five partners. The project aims to validate an immune algorithm specific to Tedopi and establish precision medicine targeting for the product. It will be conducted in conjunction with the Phase 2 clinical trial for Tedopi, combined with a PD-1 checkpoint inhibitor, in pancreatic cancer. This study, sponsored by the oncology cooperative group GERCOR, is expected to initiate in 2018.
OSE-127, humanized monoclonal antibody antagonist of the interleukin-7 receptor, in inflammatory bowel diseases

Presented new preclinical data further supporting the potential of OSE-127 for the treatment of inflammatory bowel diseases at the annual congress of the American Association of Immunologists.
Plans to initiate clinical phase in ulcerative colitis by the end of 2018, in partnership with Servier.
FR104, CD28-antagonist, in rheumatoid arthritis

Preparation for entry into a Phase 2 clinical trial in rheumatoid arthritis, in partnership with Janssen Biotech.
Moreover, the Company is continuing advancement of its innovative research program based on its several scientific and technological platforms (neoepitopes, agonist or antagonist monoclonal antibodies) positioned to fight cancer and autoimmune diseases.

Appointed Dominique Costantini as chairman of the board of directors and appointment of Alexis Peyroles to chief executive officer, a natural and seamless evolution following three structuring license agreements driving the next steps of the Company’s growth.
Strengthened the management team with the additions of Bérangère Vasseur, M.D., chief medical officer immuno-oncology (broad experience in oncology development while at Roche and at several biotechnology companies) and Emilienne Soma, PharmD, Ph.D., director of pharmaceutical program development (experience in R&D management and in alliances in several biotechnology companies).
2018 Half-Year Results

As of June 30, 2018, available cash* amounted to €18.6 million, giving a financial visibility until the second semester of 2019. Moreover, this cash could be reinforced by milestone payments provided by the partnerships with Boehringer Ingelheim, up to €15 million upon initiation of a Phase 1 of OSE-172, and with Servier, up to €12 million upon achievement of a new development step of OSE-127.

Of note, the development costs of the licensed projects are supported by the company’s partners: totally by Boehringer Ingelheim for OSE-172 and by Janssen Biotech for FR104, and partially by Servier for OSE-127. In parallel, the two public grants obtained, EFFIMab for OSE-127 and EFFI-CLIN for OSE-172, reinforce the funding.

The turnover amounted to €20.6 million, compared to €2.08 million as of June 30, 2017, due to the upfront payment from the collaboration agreement with Boehringer Ingelheim. During the first half of 2018, the Company recorded a net profit of €8.9 million.

Current operating expenses were €10.2 million, stable compared as of June 30, 2017. They include €8 million of R&D expenses during the first half of 2018. Over the same period of 2017, R&D expenses amounted to €7.9 million.

The consolidated balance sheet amounted to €84.6 million compared to €77.4 million as of December 31, 2017. This increase is mainly due to the cash received from the agreement with Boehringer Ingelheim.

*Available cash and cash equivalents and current financial assets

The Board of Directors of September 6, 2018 has approved the Company’s semester accounts as of June 30, 2018. The full "Semester financial report" (Regulated information) is available on : View Source The consolidated accounts have been subject to a limited review by the Statutory Auditors.

On September 6, 2018 PharmaMar (MCE: PHM) reported that the International Association for the Study of Lung Cancer (IASLC) has released today the abstracts for presentation during the Conference that will take place from the 23rd to the 26th of September in Toronto (Canada) (Press release, PharmaMar, SEP 6, 2018, View Source [SID1234529320]). The abstract to be presented by PharmaMar shows Overall Survival (OS) data obtained from the Phase I/II Study of lurbinectedin in combination with doxorubicin for the treatment of relapsed small-cell lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the study, PharmaMar observed Overall Survival (OS) of 10.2 months in patients treated with lurbinectedin in combination with doxorubicin, and OS of 11.5 months in platinum-sensitive patients (patients with a chemotherapy free interval (CTFI) of more than 90 days) in patients treated with lurbinectedin in combination with doxorubicin. We believe that the OS periods observed in this trial is are more favorable than those seen in historical trials of the primary treatments used for second line in small-cell lung cancer, as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).

This multicenter, Phase I/II Clinical Study enrolled patients with relapsed small-cell lung cancer (n=27) in cohort B, using the dose 2mg/m[2] of lurbinectedin + 40mg/m[2] of doxorubicin, the same dose that is being evaluated in the Phase III randomized ATLANTIS study in a similar population. In both cases the refractory patients are excluded, meaning those patients that have relapsed or have suffered a progression of the disease up to 30 days after first line treatment (CTFI <30 days).

Following the receipt of early data from this study in August 2016 PharmaMar initiated the pivotal Phase III ATLANTIS Study, that reached in July 2018 its recruitment objective of 600 patients. The trial recruited patients at 160 centers in 20 countries, and results are expected at the end of 2019.

The abstract with all this data is available on the Congress web page: View Source

Overall survival with lurbinectedin plus doxorubicin in relapsed SCLC. Results from an expansion cohort of a phase Ib trial.
Poster: P1.12-20. Monday, September 24th, 2018, from 16:45 to 18:00. Exhibit Hall.

Lead author: Martin Forster, MD. University College of London Hospital and UCL Cancer Institute, London, UK

About lurbinectedin

Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.