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 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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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

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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 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported that the first patient has been dosed in a Phase 2a trial evaluating the efficacy and safety of AVID100 in patients with squamous non-small cell lung cancer (sqNSCLC) whose tumors over express epidermal growth factor receptor (EGFR) (Press release, Forbius, OCT 22, 2018, View Source [SID1234531670]).

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Approximately 25% of patients with sqNSCLC have tumors that highly overexpress EGFR. Currently, no therapy is approved for the treatment of EGFR-overexpressing sqNSCLC.

An initial safety Phase 1 study for AVID100 was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1; 6(4):859–870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

"The sqNSCLC trial, along with additional soon-to-be launched Phase 2a trials, will provide us with important information about the efficacy of AVID100 in patients with confirmed EGFR overexpression. No therapy is approved for the treatment of EGFR-overexpressing malignancies, and AVID100 could be the first agent to address this significant unmet medical need," commented Paul Nadler, M.D., Chief Medical Officer of Forbius.

The primary goal of the Phase 2a trial is to evaluate efficacy, safety, and tolerability of AVID100 when administered to sqNSCLC patients with confirmed EGFR-overexpression. The study is being conducted at multiple sites across North America and will initially enroll approximately 15 sqNSCLC patients who failed all prior lines of treatment. The number of patients will be increased pending preliminary signs of AVID100 efficacy. This Phase 2a study is being supported by the previously announced $18.8M peer-reviewed grant from the Cancer Prevention Institute of Texas(CPRIT).

About AVID100
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development

On October 22, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Patients receiving treatment with the recommended phase 2 dose (RPTD) of pelareorep ("Reo") in combination with FOLFIRI/B (irinotecan, fluorouracil, leucovorin, plus bevacizumab) had progression free survival (PFS) of 65.6 weeks and an overall survival (OS) of 107.5 weeks, which exceeded expectations when compared to historical data (Press release, Oncolytics Biotech, OCT 22, 2018, View Source [SID1234530638]). Engagement of the adaptive immune system was also noted, suggesting that pelareorep promotes an inflamed tumor phenotype. This clinical data was presented at the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich.

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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

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"The results from the six patients in this study receiving the recommended phase two dose demonstrate a more than doubling of overall survival based on previous phase three studies using FOLRIRI with anti-VEGF therapy," said lead author, Dr. Sanjay Goel, M.D., Department of Medical Oncology, Montefiore Medical Center. "These favorable results lend support to pelareorep as a potential treatment option in this patient population with metastatic disease, that has shown disease progression on current standard-of-care chemotherapy."

Poster Presentation at ESMO (Free ESMO Whitepaper) 2018
The poster titled "Dose finding and safety study of Reovirus (Reo) with irinotecan/fluorouracil/leucovorin/bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final Results", was presented yesterday at ESMO (Free ESMO Whitepaper). This phase 1 dose escalation study enrolled 36 patients with oxaliplatin refractory KRAS mutant metastatic colorectal cancer. The trial was designed to determine the maximum tolerated dose and a RPTD.

Highlights from the Poster:
•
Of the six patients receiving the RPTD, three had a partial response (50%) and the median PFS and OS were 65.6 weeks and 107.5 weeks, respectively, exceeding expectations when compared to historical data
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Reovirus administration is marked by activation of cytotoxic T-cells and rapid maturation of dendritic cells
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Reovirus is safe and well tolerated in combination with FOLFIRI and Bevacizumab

"This impressive survival data coupled with the engagement of the adaptive immune system reinforce both the data from our metastatic breast cancer program and the increasing interest in studies combining pelareorep with immune checkpoint inhibitors," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The results presented at ESMO (Free ESMO Whitepaper) suggest the clinical utility of pelareorep may expand into multiple indications, including breast, colon and other cancers, and support our clinical development program."

Additional details can be found on the company website: View Source

References:
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Journal of Oncology, Vol. 30, Number 28, October 1, 2012
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The Lancet, Vol. 16, May 2015
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The Lancet, Vol. 14, January 2013

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On October 22, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it, along with its partner Moffitt Cancer Center (MCC), completed a pre-IND (Investigational New Drug) meeting with the US FDA on October 16, 2018 (Press release, Anixa Biosciences, OCT 22, 2018, View Source [SID1234530498]).

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The meeting was focused on discussing the development of a novel CAR-T therapy that takes advantage of specific hormone–hormone receptor biology to address ovarian cancer. Approved CAR-T therapies and others in clinical trials have demonstrated dramatic results for certain hematological cancers (also known as liquid tumors), but to date there has not been any meaningful demonstration of CAR-T efficacy against solid tumors in humans. Anixa and MCC hope their therapy will demonstrate success with ovarian cancer patients due to their unique hormone–hormone receptor approach. If successful in ovarian cancer, this approach may create a new pathway for CAR-T development against many other solid tumors.

Dr. Amit Kumar, President and CEO of Anixa Biosciences said, "It is very consequential that we have begun a dialogue with the FDA. The pre-IND meeting answered a number of questions we presented to the FDA and clarified some matters, providing us with a good understanding of the design for the clinical trial in our IND application. Further, we identified the final experiments needed to complete our IND filing. We are in the process of completing these experiments, after which we will file our IND application. The IND, after review and approval by the FDA, will enable us to test our therapy in ovarian cancer patients. Assuming the FDA approves our IND, we anticipate beginning the trial as early as the summer of 2019."

Dr. Jose Conejo-Garcia, chair of the Department of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy added, "Our CAR-T is the first in human therapy of its kind and the feedback we received from the FDA was quite helpful. We are excited to be so close to bringing our investigational therapy to ovarian cancer patients."