On September 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that it will present study updates from its Phase II clinical development programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain (07 – 10 September 2019) (Press release, BerGenBio, SEP 8, 2019, View Source [SID1234539361]).

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The two presentations will outline BerGenBio’s Phase II clinical trial (BGB008, NCT03184571) with bemcentinib and Merck’s anti-PD-1 therapy pembrolizumab (KEYTRUDA) in patients with advanced non-small cell lung cancer (NSCLC).

Data will be presented at a mini oral session entitled: Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC. As announced in June 2019, the preliminary results from the ongoing study showed promising clinical activity overall, particularly in patients with AXL positive tumours, including those with low or no PD-L1 expression. Preliminary median overall survival has reported 12.2 months, surpassing historical benchmarks in second-line treatment with PD-1 inhibitor monotherapy, especially in low PD-L1 patients; and the combination treatment was well-tolerated.

The Company will also present details of a second cohort of the Phase II trial (BGB008, NCT03184571) at a poster session, entitled: A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1. The trial has been expanded to include patients that have been previously treated with a PD-(L)1 inhibitor, or a PD-(L)1 inhibitor in combination with platinum containing chemotherapy and will further evaluate the clinical activity and safety profile of the combination.

Full abstracts are available online at View Source Materials presented at WCLC will be made available at www.bergenbio.com in the Investors / Presentations section following the sessions.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "As we continue to gather data in refractory NSCLC patients, we hope to build up a clearer picture of the potential of bemcentinib in combination with pembrolizumab. Our focus remains on enhancing responses to anti-PD-L1 therapies, particularly in patients with no or limited expression of PD-L1, who may not have benefitted from such therapies. Results to date have been encouraging, and we look forward to providing updates as further data becomes available."

BGBC008, which began in October 2017, is being conducted under a clinical collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a subsidiary, and is taking place at sites in the US, UK, Norway and Spain.

Presentation details
Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC

Enriqueta Felip et al
#MA03.06 – Clinomics and Genomics
Mini Oral Session
08 September 2019: Colorado Springs (1994), 11:05 – 11:10am CEST
A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1

Matthew Krebs et al
#P1.01-83 – Advanced NSCLC
Poster Viewing in the Exhibit Hall
08 September 2019: Exhibit Hall, 09:45am CEST
– END –

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On September 8, 2019 Amgen (NASDAQ:AMGN) reported new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutated solid tumors (Press release, Amgen, SEP 8, 2019, View Source [SID1234539360]). AMG 510 is a first-in-class investigational oral therapy that is designed to selectively and irreversibly target the KRASG12C protein. The additional follow-up in a larger group of patients with non-small cell lung cancer (NSCLC) continued to show anti-tumor activity with no dose-limiting toxicities. These data are being presented during an oral presentation at IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.

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Initial data from the Phase 1 study were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) earlier this year. The additional follow-up in a larger group of patients being presented at WCLC includes a subset of 34 NSCLC patients enrolled, with 23 of the patients being evaluable for efficacy. Thirteen of the evaluable patients received the target dose of 960 mg once daily, of which seven (54%) achieved a partial response at one or more timepoints and six (46%) achieved stable disease, for a disease control rate of 100%.

"These new data reinforce the earlier positive response rate we shared at ASCO (Free ASCO Whitepaper) in more non-small cell lung cancer patients receiving AMG 510," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance its development program both as monotherapy and in combination."

Among the 34 NSCLC patients enrolled, there were no observed dose-limiting toxicities and no adverse events leading to discontinuation. Twenty-seven of these patients remain on treatment. Of the 34 patients, only nine (26.5%) reported treatment-related adverse events (TRAEs) of grade 1 or 2. Three patients reported grade 3 TRAEs (anemia and diarrhea). There were no grade 4 or higher TRAEs.

"There is a need for targeted treatments for specific driver mutations of cancer that do not have an approved therapy," said Ramaswamy Govindan, M.D., principal investigator and professor at Washington University School of Medicine in St. Louis. "These data continue to show encouraging anti-tumor activity with AMG 510, underscoring the potential to close the treatment gap for non-small cell lung cancer patients with previously treated KRAS G12C-mutated NSCLC."

Additional data on AMG 510 will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain from Sept. 27-Oct. 1.

About the Phase 1 Study
The Phase 1, first-in-human, open-label multicenter study enrolled patients with KRAS G12C mutant solid tumors. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint is safety, and key secondary endpoints include pharmacokinetics, objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C accounts for approximately 13% of non-small cell lung cancers, 3-5% of colorectal cancers and one to two percent of numerous other solid tumors.3 Approximately 30,000 patients are diagnosed each year in the United States with KRAS G12C-driven cancers.4 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

For more information, follow us on www.twitter.com/amgenoncology.

On September 8, 2019 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, reported that Vu Truong, Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 21st Annual Global Investment Conference (Press release, Aridis Pharmaceuticals, SEP 8, 2019, https://www.prnewswire.com/news-releases/aridis-pharmaceuticals-to-present-at-the-hc-wainwright-21st-annual-global-investment-conference-on-september-10-2019-300913758.html [SID1234539359]).

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Date: Tuesday, September 10, 2019
Time: 12:30 pm Eastern Time
Location: Lotte New York Palace Hotel

On September 8, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the company will hold a conference call and webcast on Sunday, September 8, 2019, at 7:00 p.m. ET | Monday, September 9, 2019, at 7:00 a.m.Hong Kong time, prior to the open of trading on the Hong Kong Stock Exchange (Press release, BeiGene, SEP 8, 2019, View Sourcenews-releases/news-release-details/beigene-hold-conference-call-and-webcast-september-8-2019-700-pm" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-hold-conference-call-and-webcast-september-8-2019-700-pm" rel="nofollow">View Source [SID1234539358]). On the call, Company management will provide information related to a recent short seller report commenting on the Company’s operations .

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Conference Call and Webcast Information
Investors and analysts are invited to join the conference call using the following dial-in information:
U.S. Toll-Free: (844) 461-9930
Hong Kong: 5819-4851
China: 400-682-8609
Conference ID: 7797578

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

On September 8, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) and Servier reported initial safety and efficacy data from Part 1 of the Phase II/III RESILIENT study of investigational liposomal irinotecan (ONIVYDE) in patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen (Press release, Ipsen, SEP 8, 2019, View Source [SID1234539356]). The results, which included preliminary safety and efficacy data, were presented as an oral presentation at the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, 7-10 September 2019.

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The RESILIENT (NCT03088813) trial is a randomized, open-label two-part Phase II/III study assessing the safety, tolerability and efficacy of investigational liposomal irinotecan as a monotherapy for SCLC patients who have progressed on or after a first-line platinum-based regimen. The trial is being conducted in two parts. Part 1 includes dose-finding and dose-escalation analyses to determine the appropriate dose of study drug where the primary endpoints are safety and tolerability. Part 2 has just been initiated with the first patients randomized and will focus on efficacy assessments versus the current standard of care, topotecan, including progression-free survival (PFS) and overall survival (OS).

"Immunotherapies and combination therapies have proven beneficial in the first-line setting, but despite these advances, many small cell lung cancer patients rapidly relapse due to the aggressive nature of the disease," said Luis G. Paz-Ares, M.D., Ph.D., lead investigator and chief physician, Hospital Universitario 12 de Octubre, Madrid. "While the current standard of care in the second-line setting can extend survival, treatment toxicity has prevented some patients from receiving the full recommended dose. There is a clear need for more treatment options that may give more patients the chance to remain on therapy. It is positive that the RESILIENT trial will continue to investigate this."

ONIVYDE (liposomal irinotecan) is a topoisomerase inhibitor featuring a liposomal formulation of irinotecan that is designed to prolong its circulation before conversion to its active form. This unique mechanism of delivery was evaluated in the NAPOLI-1 Phase III study, which led to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of ONIVYDE in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy. ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

"ONIVYDE has been proven to help many metastatic pancreatic cancer patients whose disease has progressed following gemcitabine-based therapy to live longer," said Yan Moore, M.D., Ipsen’s Senior Vice President, Head of Oncology Therapeutic Area. "By applying this research to other hard-to-treat-cancers, like small cell lung cancer, we aim to evaluate the potential benefit investigational ONIVYDE may bring to patients who otherwise would have limited treatment options."

"The data presented today shows that further research is warranted, and we look forward to working with Ipsen and our investigators to understand the full potential of bringing new treatment options to small cell lung cancer patients," said Patrick Therasse, M.D., Ph.D., Head of Servier Research and Development Oncology.

Part 1 of the study enrolled 30 patients (median age = 60 (48-73) years) who were treated every two weeks for >12 weeks, with tumor assessments taking place every six weeks. During the dose-finding phase, five patients received liposomal irinotecan 85mg/m2. This dose was deemed not tolerable due to dose limiting toxicity. An additional 12 patients received liposomal irinotecan 70mg/m2, which was deemed tolerable. Thirteen more patients were enrolled in the dose expansion phase of the study at this dose. As of the May 8, 2019 data cut off, a total of 25 patients had received liposomal irinotecan 70mg/m2.

Safety Results:

Liposomal irinotecan 70mg/m2 was generally well-tolerated with Grade 3 or higher treatment emergent adverse events (TEAEs) reported by 10 out of 25 patients.
Diarrhea was the most common Grade 3 gastrointestinal TEAE (n=5).
Hematologic Grade 3 or higher TEAEs included neutropenia (n=4) anemia (n=2) and thrombocytopenia (n=2).
One reported instance of Grade 3 or higher fatigue.

Efficacy Results:

Best overall response (partial response plus stable disease) was 72% with an objective response rate of 44%.
44% (11/25) of patients achieved a partial response with 68% of patients (17/25) experiencing tumor shrinkage.
48% of patients maintained disease control at 12-weeks (DCR12wks PR+SD).
Data for OS and PFS are still maturing.