More than 60 Late Breaking Abstracts (LBA’s) were published at this year’s European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (E.S.M.O 2018). Below you will find the 16 published at the sessions on Monday 22nd October, the fourth and final day of the conference.

For full analysis identifying new technologies, drugs, targets, start-ups etc. we recommend Commercial Interest at E.S.M.O Annual Meeting 2018: Analytical Tool.

• LBA8_PR – KEYNOTE-048: Phase 3 study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)
• LBA9_PR – Cetuximab versus cisplatin in patients with HPV-positive, low risk oropharyngeal cancer, receiving radical radiotherapy
• LBA10 – Primary results of ALESIA: A randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naïve ALK+ advanced NSCLC
• LBA18_PR – Durable Clinical Benefit With Nivolumab (NIVO) Plus Low-Dose Ipilimumab (IPI) as First-Line Therapy in Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) Metastatic Colorectal Cancer (mCRC)
• LBA19 – Fluoropyrimidine (FP) + bevacizumab (BEV) + atezolizumab vs FP/BEV in BRAFwt metastatic colorectal cancer (mCRC): Findings from Cohort 2 of MODUL – a multicentre, randomized trial of biomarker-driven maintenance treatment following first-line induction therapy
• LBA20 – TRIBE2: a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable metastatic colorectal cancer (mCRC) patients (pts).
• LBA21 – InterAACT: A multicentre open label randomised phase II advanced anal cancer trial of cisplatin (CDDP) plus 5-fluorouracil (5-FU) vs carboplatin (C) plus weekly paclitaxel (P) in patients (pts) with inoperable locally recurrent (ILR) or metastatic treatment naïve disease – An International Rare Cancers Initiative (IRCI) trial.
• LBA37_PR – Neoadjuvant ipilimumab plus nivolumab in early stage colon cancer
• LBA42 – OpACIN-neo – A Multicenter Phase 2 Study to identify the Optimal neo-Adjuvant Combination scheme of Ipilimumab (IPI) and Nivolumab (NIVO).
• LBA43 – Updated relapse-free survival (RFS) and biomarker analysis in the COMBI-AD trial of adjuvant dabrafenib + trametinib (D + T) in patients (pts) with resected BRAF V600–mutant stage III melanoma
• LBA44 – Overall survival at 4 years of follow-up in a phase 3 trial of nivolumab plus ipilimumab combination therapy in advanced melanoma (CheckMate 067)
• LBA52 – Results of the GEOMETRY mono-1 phase II study for evaluation of the MET inhibitor capmatinib (INC280) in patients (pts) with METΔex14 mutated advanced non-small cell lung cancer (NSCLC)
• LBA53 – IMpower130: Progression-free survival (PFS) and safety analysis from a randomised phase 3 study of carboplatin + nab-paclitaxel (CnP) with or without atezolizumab (atezo) as first-line (1L) therapy in advanced non-squamous NSCLC
• LBA54 – IMpower132: efficacy of atezolizumab (atezo) + carboplatin (carbo)/cisplatin (cis) + pemetrexed (pem) as 1L treatment in key subgroups with stage IV non-squamous non-small cell lung cancer (NSCLC)
• LBA55 – Primary efficacy results from B-F1RST, a prospective Phase II trial evaluating blood-based tumour mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC)
• LBA56 – Maintenance chemotherapy versus follow-up after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC): IFCT-1201 MODEL randomised phase 3 trial

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On October 22, 2018 Taiho Pharmaceutical Co., Ltd. and Servier reported that the clinical data from the pivotal Phase III (TAGS) trial were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress held in Munich, Germany, from October 19 to 23 (Press release, Taiho, OCT 22, 2018, View Source [SID1234530335]). The study results were simultaneously published in The Lancet Oncology. Based on the results, Servier filed a new application for an additional indication for gastric cancer to the European Medicines Agency (EMA) for LONSURF.

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The TAGS trial evaluates LONSURF (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) cancers who have progressed or are intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. TAGS, a phase 3, randomised, double-blind study of trifluridine/tipiracil (TAS-102) versus placebo in patients with refractory metastatic gastric cancer (Abstract #LBA25), data were presented by Hendrik-Tobias Arkenau, MD, PhD, from the Sarah Cannon Research Institute UK at the ESMO (Free ESMO Whitepaper) 2018 Congress during an oral session on Sunday, October 21 at 11:10 AM CEST.

In the TAGS trial, patients treated with LONSURF showed a clinically meaningful and statistically significant improvement in OS compared with placebo, a 31 percent risk reduction of death (HR 0.69), which translated into a prolongation of median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo). In addition, LONSURF demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo, as well as a predictable and manageable safety profile consistent with that previously reported in patients with metastatic colorectal cancer (mCRC). Taiho Pharmaceutical and Servier remain committed to making further contributions to patients and to medical practitioners engaged in the treatment of cancer.

About TAGS
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine/tipiracil), also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial is overall survival (OS), and the main secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

The TAGS trial aimed to enroll 500 adults 18 years and older, with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The trial enrolled 507 subjects and was conducted in Japan, the United States, the European Union, Russia, Belarus, Israel, and Turkey.

For more information on the TAGS trial, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About Gastric Cancer
Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually1 . In Japan, gastric cancer is
the most common cancer and the third most common cause of cancer-related death (after lung and colorectal cancer), causing around 45,000 deaths annually2
.
In recent years, the outcome for gastric cancer has improved remarkably, and survival has increased dramatically over the past 10 years. As cancer progresses, however, numerous complications can limit the usable drugs and preclude intensive chemotherapy. Prolonging survival and relieving symptoms in late-stage treatment for metastatic gastric cancer are issues for which it is thought important to increase the options for new therapeutic drugs. At present, nivolumab and irinotecan are recommended in Japan as the standard third line treatment for metastatic
gastric cancer.

About LONSURF
LONSURF (trifluridine/tipiracil) is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S.
subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

In 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TYY Biopharm launched LONSURF in
Taiwan in July 2018, and Jeil Pharmaceutical is preparing to bring the drug to market in South Korea.

As of October 2018, LONSURF has been approved as a treatment for mCRC in 61 countries and regions worldwide.

On October 22, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that its third quarter 2018 financial results will be released after market close on Thursday, November 8, 2018 (Press release, Coherus Biosciences, OCT 22, 2018, View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" rel="nofollow">View Source [SID1234531696]). Starting at 4:30 p.m. ET, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing third quarter 2018 financial results, we will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, November 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7181479
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On October 22, 2018 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, presented clinical trial data from its lead oncology drug candidate, AMC303, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich (Press release, amcure, OCT 22, 2018, View Source [SID1234530042]). The data presented on Sunday, 21 October in a proffered oral presentation demonstrated the favorable safety profile of AMC303. The company is currently conducting a Phase 1b expansion cohort and expects to publish updates from the study in 2019.

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AMC303 is a cyclic peptide targeting CD44v6, a key cell membrane protein in pathways of several receptor-tyrosine kinases, such as c-MET, VEGFR-2 and RON. This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body. Trial results presented at ESMO (Free ESMO Whitepaper) 2018 have shown the compound to be well-tolerated in 27 patients with a total of 11 different cancer types, with a favorable PK profile. No related serious adverse events (SAEs) were reported, and most frequently reported related events were infusion related reactions and hypersensitivity (grade 1-2, in 22% of patients), followed by nausea, diarrhea and fatigue.

"AMC303 was well tolerated in a heavily pretreated and diverse cancer patient population. The most related adverse events were transient and manageable. AMC303 has thus the potential of being a safe therapeutic option with a unique and additive mechanism of action," said Dr. Emiliano Calvo, MD, Lead Investigator of the trial at the Hospital Madrid Norte Sanchinarro and Director at the START Madrid-CIOCC Early Phase Clinical Drug Development program.

"These encouraging data support the continuation of the trial into its second part, targeting patients with a moderate to high expression of the target molecule CD44v6 and selected cancer types with a confirmed squamous cell histology. We look forward to updating the community on the progress of this trial and publish additional data sets as they emerge," added Klaus Dembowsky, CEO of amcure GmbH.

The trial, conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. In addition, the study includes a comprehensive biomarker program. The study was designed to include a broad variety of tumor types in the first part of the study irrespective of the target expression and a tumor type-specific expansion cohort at the recommended dose for a subsequent Phase 2 study. With the expansion cohort, amcure focuses its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

For more information on the trial please visit View Source

About AMC303
amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

On October 22, 2018 Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet patient needs in aesthetic and medical dermatology and immunology, reported the closing of its underwritten public offering of 9,941,750 shares of its common stock at a price to the public of $10.75 per share, which includes the full exercise of the underwriters’ option to purchase 1,296,750 additional shares, for total gross proceeds of approximately $106.9 million, before deducting underwriting discounts and commissions and offering expenses (Press release, Aclaris Therapeutics, OCT 22, 2018, View Source [SID1234530061]). All of the common stock in the offering was sold by Aclaris.

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Leerink Partners and Evercore ISI acted as joint book-running managers for the offering. Cantor acted as lead manager for the offering. Guggenheim Securities acted as co-manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on November 2, 2016 and declared effective by the SEC on November 14, 2016. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.