t epotinib c-Met kinase inhibitor Non-small cell lung cancer tepotinib c-Met kinase inhibitor Hepatocellular cancer avelumab anti-PD-L1 mAb Merk el cell cancer 1L 1 sprifermin fibroblast growth factor 18 O steoarthritis atacicept anti-Blys /anti-APRIL fusion protein Systemic lupus erythematosus atacicept anti-Blys /anti-APRIL fusion protein IgA nephropathy abituzumab anti-CD 51 mAb Systemic sclerosis with interstitial lung dis. evobrutinib BTK inhibitor R heumatoid arthritis evobrutinib BTK inhibitor Systemic lupus erythematosus evobrutinib BTK inhibitor Multiple sclerosis 1 Merck pipeline M2698 p70S6K & Akt inhibitor Solid tumors M3814 DNA-PK inhibitor Solid tumors M9831 (VX-984) DNA-PK inhibitor Solid tumors M6620 (VX-970) ATR inhibitor Solid tumors M4344 (VX-803) ATR inhibitor Solid tumors M7583 BTK inhibitor Hem atological malignancies avelumab anti-PD-L1 mAb Solid tumors avelumab anti-PD-L1 mAb Hem atological malignancies M9241 (NHS-IL12) 8 Cancer immunotherapy Solid tumors M7824 anti-PD-L1/ TGFbeta trap Solid tumors M1095 (ALX-0761) 10 anti-IL-17 A/F nanobody Psoriasis Registration Phase III Phase II Phase I cladribine 4 tablets lymphocyte targeting agent Relapsing-remitting multiple sclerosis avelumab 6 anti-PD-L1 mAb Merk el cell cancer (EU) avelumab-anti-PD-L1 mAb Non-small cell lung cancer 1L 1 avelumab-anti-PD-L1 mAb Non-small ce ll lung cancer 2L 2 avelumab-anti-PD-L1 mAb Gastric cancer 1L-M 1M avelumab-anti-PD-L1 mAb Gastric cancer 3L 3 avelumab-anti-PD-L1 mAb O varian cancer platinum resistant/refractory avelumab-anti-PD-L1 mAb O varian cancer 1L 1 avelumab-anti-PD-L1 mAb Urothelial cancer 1L-M 1M avelumab-anti-PD-L1 mAb Renal cell cancer 1L 1 avelumab-anti-PD-L1 mAb Locally advanced head and neck cancer MSB 11022 9 proposed biosimilar of adalimumab Chronic plaque psoriasis 1 First Line treatment; 1M First Line maintenance treatment; 2 Second Line treatment; 3 Third Line treatment; 4 As announced on July 18, 2016, the EMA has accepted for review the Marketing Authorization Application (MAA) of Cladribine Ta ble ts for the treatment of relapsing-remitting multiple sclerosis. 5 As announced on March 23, 2017, the US FDA has granted accelerated approved of avelumab for the treatment of adults and pedia tri c patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for metastatic MCC outside of the US. 6 As announced on October 31, 2016, the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of m eta static Merkel cell cancer. 7 As announced on May 9, 2017 the US FDA granted accelerated approval of avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved f or metastatic UC outside of the US. 8 Sponsored by the National Cancer Institute (USA). 9 On April 24, 2017 the divestment of Merck’s Biosimilars business to Fresenius was announced. Closing is expected in H2, 2017, s ubject to regulatory approvals and other conditions. 10 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. May 18, 2017 Recently Registered avelumab 5-anti-PD-L1 mAb Merk el cell cancer (US) avelumab 7-anti-PD-L1 mAb Urothelial cancer (US) Neurology Oncology Immunology Immuno-Oncology B iosimilars P ipeline products are under clinical investigation and have not been proven to be s afe and effective. T here is no guarantee any product will be approved in the s ought-after indication.

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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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Background: FGFR2b-overexpressing gastric cancer is characterized by poor prognosis. FPA144, a humanized monoclonal IgG1 antibody that specifically binds to and blocks FGFR2b, has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). FPA144-001 is a two-part Phase 1 study of FPA144 monotherapy in patients with advanced solid tumors, including gastric and gastroesophageal cancers (GEJ cancers).
Methods: Part 1A was a 3+3 design to assess safety and PK and to establish a recommended dose (RD) of FPA144. Patients with gastric cancer were enrolled in Part 1B to assess PK in gastric cancer. Part 2 includes 4 cohorts of gastric cancer patients with either high, moderate, low or no FGFR2b overexpression based on a centralized immunohistochemistry (IHC) assay. Here, we describe results of gastric cancer patients that highly overexpress FGFR2b (FGFR2b+ High) enrolled in Parts 1 and 2 of the study.
Results: As of October 28, 2016, 18 FGFR2b+ High (IHC 3+ ³10% tumor membrane staining) patients were enrolled in the study. 12 of these patients received the RD of 15 mg/kg every 2 weeks. Enrolled patients received a median of 3 prior treatment regimens. Fatigue (22.2%, none ³ gr 3) and infusion reaction (16.7%, 5.6% gr 3) were the most common treatment-related AEs. Treatment-related SAEs were reported in 2 patients: Grade 2 ulcerative keratitis and Grade 3 infusion reaction. There were 5 PRs, 4 confirmed and 1 unconfirmed. Disease control (PR+SD) was 55.6%, including a confirmed ORR of 22% with median DOR of 15.4 weeks. ctDNA analysis of a responding patient revealed baseline elevated FGFR2 gene copy (165 copies in the blood, mutation allele burden 66%) that decreased after monotherapy (nadir 75 copies, mutation allele burden 38.5%) corresponding with clinical response, serum tumor markers and near complete response on PET imaging.
Conclusions:
The demonstration of activity and an acceptable safety profile supports further development of FPA144 in patients with FGFR2b+ tumors. FGFR2 gene amplification detected in ctDNA may provide a non-invasive diagnostic test for patient selection. Updated data will be presented. NCT02318329.

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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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On May 18, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting new study results for its in-house discovered lenvatinib mesylate (selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, product name: Lenvima / Kisplyx, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven, "eribulin"), as well as H3B-8800, a splicing modulator discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be presented during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place in Chicago, the United States, from June 2 to 6, 2017 (Press release, Eisai, MAY 18, 2017, View Source [SID1234519265]).

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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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Detailed data regarding the results of a Phase III clinical trial (Study 304) of lenvatinib compared with sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma, which has already achieved its primary endpoint, will be presented orally at the ASCO (Free ASCO Whitepaper) Annual Meeting. This presentation is scheduled to take place on Sunday, June 4, 8:12 AM local time, in Hall D2.

Major poster presentations will include a highlight of the results of a Phase Ib/II clinical trial (Study 111) of lenvatinib in combination with the anti-PD-1 antibody pembrolizumab for the treatment of patients with endometrial carcinoma, and the results of a Phase I clinical trial of H3B-8800 in patients with advanced myeloid malignancies.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

Oral Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 4001 Phase 3 trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC)
Oral Presentation | June 4 (Sun), 8:12-8:24 AM
Major Poster Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 5598 A Phase Ib/II Trial of Lenvatinib (LEN) Plus Pembrolizumab (Pembro) in Patients (Pts) With Endometrial Carcinoma
Poster Presentation | June 3 (Sat), 1:15-4:45 PM
Lenvatinib

Abstract No: TPS4595 A Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab vs Sunitinib Alone in First-Line Treatment of Patients with Advanced Renal Cell Carcinoma
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Lenvatinib

Abstract No: 10544 Single-agent Dose-finding Cohort of a Phase 1/2 Study of Lenvatinib (LEN) in Children and Adolescents with Refractory or Relapsed Solid Tumors
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Eribulin

Abstract No: 6603 Validity and Reliability of Four Value Frameworks for Cancer Drugs

Poster Presentation | June 5 (Mon), 1:15-4:45 PM
H3B-8800

Abstract No: TPS7075 H3B-8800-G0001-101: A first in human phase I study of a splicing modulator in patients with advanced myeloid malignancies
Poster Presentation | June 5 (Mon), 8:00-11:30 AM

On May 18, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported the release of abstracts containing new data from the ongoing Phase 2 clinical trial of its product candidate GMI-1271, an E-selectin antagonist, in patients with acute myeloid leukemia (AML) (Press release, GlycoMimetics, MAY 18, 2017, View Source [SID1234519253]). The data will be presented at the June annual meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper). The data released by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), which reflect a late-January analysis, will be updated in posters presented at both meetings.

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In the ongoing Phase 2 trial, AML patients treated with GMI-1271, combined with chemotherapy, continue to experience higher-than-expected remission rates and lower-than-expected induction-related mortality rates in both arms of the trial. In addition, researchers have observed that baseline expression of the E-selectin ligand biomarker on leukemia cells was predictive of clinical response and tied to greater likelihood of achieving remission in the cohort of AML patients with relapsed/refractory disease, which supports the mechanism of action of GMI-1271. Treatment with GMI-1271 continues to be well tolerated, with no obvious incremental toxicity observed when GMI-1271 is added to chemotherapy.

According to Helen Thackray, MD, Chief Medical Officer, "The data has consistently shown good tolerability and high remission rates as well as lower than expected 30- and 60-day mortality rates in early evaluations of patients. We are increasingly confident that our investigational drug, GMI-1271, may play a role in addressing unmet needs in this cancer. It is particularly noteworthy to see in the relapsed/refractory cohort that patients who have higher levels of the E-selectin ligand biomarker on their leukemic blasts appear to be more likely to achieve remission of their disease. This observation builds directly on what we and others have reported in the preclinical and clinical settings about the key role E-selectin plays in many forms of cancer, including AML. Importantly, this provides what we believe is the first direct clinical evidence of the potential benefit of targeting of E-selectin in this difficult-to-treat population of AML patients."

Relapsed or Refractory Disease Arm: Abstract Data

Consistent with GlycoMimetics’ prior published research, the addition of GMI-1271 to mitoxantrone, etoposide and cytarabine (MEC) chemotherapy has been well-tolerated, with patients achieving a high overall response rate (ORR), low induction mortality, and promising initial survival outcomes. The data show that baseline expression of the E-selectin ligand biomarker was predictive of response. GlycoMimetics believes these results are better than what would be expected in this population, based on published historical controls in similar patients.

Highlights of the data reported in the published abstract include:

47 patients were enrolled.
30- and 60-day mortality were 0 and 7%, respectively.
ORR was 21/42 evaluable (50%).
Median Overall Survival in the Phase 1 portion was 7.6 months.
The median E-selectin ligand binding at baseline was 35% of blasts (range, 1-75%) and, importantly, was higher in those achieving remission.
The data from the ongoing Phase 2 trial were submitted to the U.S. Food and Drug Administration (FDA). As announced yesterday, GMI-1271 was granted Breakthrough Therapy designation from the FDA for the treatment of adult AML patients with relapsed/refractory disease. The FDA had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 for the treatment of AML.

Newly Diagnosed, Treatment-Naïve, Elderly Arm: Abstract Data

In the published abstract, data reflects 17 of 24 enrolled and evaluable elderly patients. Highlights from the abstract include:

The remission rate (CR/CRi) was 12/17 (71%).
CR/CRi rate was 75% for patients with de novo disease and 67% for patients with secondary AML.
GlycoMimetics noted that the safety profile of the investigational drug, GMI-1271, in combination with chemotherapy is encouraging. Outcomes for elderly patients with AML remain poor, and tolerability of treatments is a key concern.