Incyte Announces Data for Pemigatinib, its Selective FGFR Inhibitor, to be Featured at the ESMO 2018 Congress

On October 9, 2018 Incyte (Nasdaq:INCY) reported that interim Phase 2 data on its investigational, selective FGFR1/2/3 inhibitor, pemigatinib (INCB54828), will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19-23, 2018 (Press release, Incyte, OCT 9, 2018, View Source [SID1234529818]).

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Data at ESMO (Free ESMO Whitepaper) 2018 will include poster presentations on the FIGHT-202 study of pemigatinib in patients with previously treated advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) with fibroblast growth factor (FGF)/FGFR genetic alterations, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (bladder cancer) harboring FGF/FGFR genetic alterations.

"We are pleased that data on pemigatinib – part of our targeted therapy portfolio – have been selected for presentation at this year’s ESMO (Free ESMO Whitepaper) Congress," stated Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing updated interim data from the ongoing FIGHT-202 trial of pemigatinib in patients with cholangiocarcinoma, which continue to support our plan for a 2019 NDA submission in this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which support recruitment into the continuous dosing cohort of this study."

Abstracts were made available today on the ESMO (Free ESMO Whitepaper) Congress website at View Source

Poster details:

Interim Results of FIGHT-202, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) with/without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations (Abstract #756P, poster display session)

Sunday, 21 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub
Interim Results of FIGHT-201, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Metastatic or Surgically Unresectable Urothelial Carcinoma (UC) Harboring Fibroblast Growth Factor (FGF)/FGF receptor (FGFR) Genetic Alterations (GA) (Abstract #900P, poster display session)

Monday, 22 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub
Full session details and data presentation listings for ESMO (Free ESMO Whitepaper) 2018 can be found at:
View Source

About FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.

PharmaCyte Biotech Announces Publication of PCT Patent Application for Cancer Therapies

On October 9, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its PCT patent application covering a targeted therapy to treat solid cancerous tumors was published on September 27, 2018 (Publication No. WO 2018/175576) (Press release, PharmaCyte Biotech, OCT 9, 2018, View Source [SID1234529817]). It was titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof." This PCT application allows PharmaCyte to file patent applications and seek protection in most major market countries throughout the world. These patent applications, if granted, will provide protection for PharmaCyte’s technology for 20 years without a gap in patent protection – until March 2038.

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Kenneth L. Waggoner, PharmaCyte Biotech’s Chief Executive Officer, commented "The publication of this PCT patent application is a significant step in being able to protect our unique cancer therapy for many years to come. It is particularly important now as we get closer to beginning our clinical trial in patients with locally advanced pancreatic cancer (LAPC). However, in addition to pancreatic cancer, the Cell-in-a-Box live cell encapsulation technology also gives us opportunities to develop unique therapies for other forms of cancer where new treatment modalities are needed."

The PCT application also specifically includes methods of treating other cancerous tumors, such as those of the liver, breast and colon, using the live-cell encapsulation of genetically modified human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver. These cells are encapsulated using the proprietary Cell-in-a-Box technology. Together with low doses of a drug of the oxazaphosphorine class, ifosfamide, the encapsulated cells comprise PharmaCyte’s therapy for pancreatic cancer. The patent application also includes using PharmaCyte’s platform technology with cyclophosphamide, another chemotherapy drug of the oxazaphosphorine class that is activated by the cytochrome P450 enzyme system. In the case of pancreatic cancer, it is hoped that the Cell-in-a-Box plus low dose ifosfamide combination will be beneficial to patients whose pancreatic tumors become resistant to standard chemotherapies such as the combination of the anticancer drugs gemcitabine and Abraxane or FOLFIRINOX. The use of Cell-in-a-Box encapsulation with other drugs against other forms of cancer remains to be investigated.

The PCT patent application originated from a provisional patent application by the same title that was filed with the U.S. Patent and Trademark Office (USPTO) on March 21, 2017 and a patent application by the same title that was filed with the USPTO on March 21, 2018.

OncoSec Announces Closing of First Tranche of $15 Million At Market Investment from Alpha Holdings, Inc.

On October 9, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the closing of the first $8 million tranche of its $15 million investment from Alpha Holdings, Inc. (KOSDAQ: 117670) (Press release, OncoSec Medical, OCT 9, 2018, View Source [SID1234529816]). This value-focused, fundamental strategic investment is centered on the clinical development of OncoSec’s lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

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Alpha Holdings is a leading Korean technology company engaged in the design, development, service and manufacture of system semiconductors, as well as the development of biotechnologies and thermal compound materials. Since 2002, Alpha Holdings has successfully carried out many projects as a major partner of Samsung Advanced Foundry Eco-system (SAFE) of Samsung Electronics. Alpha Holdings, a listed company in the KOSDAQ Market, was founded in 2002 and is headquartered in Seongnam, South Korea.

Under the terms of the agreement, Alpha Holdings has committed to purchase a total of $15 million worth of shares of common stock from OncoSec in two tranches at $1.50 per share. The two tranches are each subject to a six-month holding requirement from date of funding. As stated above, Alpha has funded the first tranche of $8 million. The closing of the second tranche is subject to the satisfaction of certain closing conditions. Further details of the transaction can be found in the Form 8-K filed by the Company describing the agreement.

AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018

On October 9, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that it will present 54 abstracts, including eight oral presentations and three late breakers, to the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) Congress in Munich, Germany, 19-23 October (Press release, AstraZeneca, OCT 9, 2018, View Source [SID1234529815]).

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Data span several tumour types and include full results from the Phase III SOLO-1 ovarian cancer trial to be presented in the Presidential Symposium, along with new research on resistance mechanisms in metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). In addition, MedImmune Senior Vice President, Head of Oncology Innovative Medicines and Professor of Medicine and Medical Oncology at South-Paris University, Jean-Charles Soria, will be recognised for his outstanding contribution to medical oncology by receiving the 2018 ESMO (Free ESMO Whitepaper) Award.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit, said: "Our diversified Oncology portfolio prioritises medicines with the potential to redefine the clinical practice of cancer treatment. We are working to deliver potentially curative approaches earlier in the treatment paradigm across a range of cancers. We are also exploring how to stay a step ahead of disease progression by understanding how tumours become resistant to treatment over time."

Detailed Lynparza data from the Phase III SOLO-1 trial in women with newly-diagnosed, advanced BRCA-mutated ovarian cancer

SOLO-1 is the only trial of a poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza, to demonstrate a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women with newly-diagnosed, advanced BRCA-mutated ovarian cancer. Data from the trial by AstraZeneca and MSD, known as Merck in the US and Canada, will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (Presentation #LBA7_PRAbstract). In the 1st-line setting, only 20 percent of women have prolonged, relapse-free periods and are considered cured following surgery and chemotherapy, and 70 percent relapse within three years. These data will provide detailed PFS results for Lynparza, supporting the treatment goal of long-term remission in women with newly-diagnosed disease, where currently-available treatment options aimed at extending time to progression only offer modest improvements.

New understanding of acquired resistance mechanisms in lung cancer from the Phase III FLAURA trial

Preliminary data on acquired resistance mechanisms seen with 1st-line Tagrisso (osimertinib) use in the Phase III FLAURA trial (Presentation Number #LBA_5005) will be presented as a late-breaker, providing new insights into potential treatment strategies for patients with metastatic EGFR-mutated NSCLC.

Lung cancer Immuno-Oncology (IO): New insights from the Phase III PACIFIC trial

An oral presentation of subgroup analyses will explore the efficacy and safety of the PACIFIC regimen in unresectable, Stage III NSCLC evaluating differences in treatment and timing for chemoradiation therapy before Imfinzi (Abstract #1363O).

Early pipeline explores combinations in difficult-to-treat tumour types

Key presentations from AstraZeneca’s early stage pipeline include insight into novel DNA Damage Response (DDR)-IO combinations. A Phase I clinical and translational evaluation of the ATR inhibitor, AZD6738, in combination with Imfinzi in patients with lung or head and neck cancer will be featured as a poster discussion (Abstract #413PD).

Data from the early-stage IO pipeline, including updated results from the Phase Ib/II multi-indication SCORES trial of Imfinzi plus danvatirsen (AZD9150, STAT3) or AZD5069 (CXCR2), demonstrating the impact of targeting novel pathways, will also be presented (Abstract #1044O).

Additionally, new approaches to patient selection using different methods of detection of homologous recombination repair gene mutations will be highlighted in a Phase II trial of Lynparza plus abiraterone (Study 08) in metastatic castration-resistant prostate cancer (Abstract #97P).

Key AstraZeneca/MedImmune presentations at ESMO (Free ESMO Whitepaper) 2018:

Lead author

Abstract title

Presentation details

Ovarian cancer

Moore, K

Phase III SOLO1 trial: Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced stage ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm)

Oral Presentation

Presidential Symposium 2

Sunday 21st October, 16:30-18:10

Presentation Time: 17:45-18:00

Location: Hall A2, Room 18

Abstract #LBA7_PR

Penson, RT

MEDIOLA: A Phase I/II trial of olaparib (PARP inhibitor) in combination with durvalumab (anti-PD-L1 antibody) in patients with advanced solid tumors – new ovarian cancer cohorts

Poster

Gynaecological cancers

Monday 22nd October, 12:45-13:45

Location: Hall A3

Abstract #448TiP

Colombo, N

BAROCCO: A randomized phase II study of weekly paclitaxel vs. cediranib-olaparib with continuous schedule vs. cediranib-olaparib with intermittent schedule in advanced platinum-resistant ovarian cancer

Poster

Gynaecological cancers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #1002TiP

Lung Cancer

Ramalingam, S

Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study

Oral Presentation

NSCLC, metastatic

Friday 19th October, 16:00-17:30

Presentation Time: 16:00-16:12

Location: Hall A2, Room 18

Abstract #LBA50

Faivre-Finn, C

Efficacy and safety evaluation based on time from completion of radiotherapy to randomization with durvalumab or placebo in pts from PACIFIC

Oral Presentation​

Non-Metastatic NSCLC and Other Thoracic Malignancies

Sunday 21st October, 09:15-10:45

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17
Abstract #1363O

Kowalski, D

ARCTIC: durvalumab + tremelimumab and durvalumab monotherapy vs SoC in ≥3L advanced NSCLC treatment

Oral Presentation ​

NSCLC, metastatic

Monday 22nd October, 09:15-11:00​

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17​

Abstract #1378O

Bondarenko, I

Preliminary efficacy of durvalumab plus tremelimumab in platinum-refractory/resistant ED-SCLC from Arm A of the Phase II BALTIC study

Poster Discussion

Lung early

Sunday 21st October, 14:45-16:00

Discussion Time: 15:25-15:35

Location: ICM, Room 1

Abstract #1665PD

Early pipeline

Cohen, EW

Phase 1b/2 Study (SCORES) of Durvalumab (D) Plus AZD9150 or AZD5069 in Advanced Solid Malignancies and Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M-SCCHN): Updated Results

Oral Presentation

Head & Neck cancer
Monday 22nd October, 14:45-16:15

Presentation Time: 14:45-15:00

Location: ICM, Room 14b
Abstract #1044O

Krebs, MG

Phase I clinical and translational evaluation of AZD6738 in combination with durvalumab in patients (pts) with lung or head and neck carcinoma

Poster Discussion

Developmental therapeutics

Saturday 20th October, 15:00-16:15

Discussion Time: 15:00-15:20

Location: Hall B3, Room 22

Abstract #413PD

Carr, Thomas H

Multimodal detection of homologous recombination repair gene mutations (HRRm) in a Phase II trial of olaparib plus abiraterone in metastatic castrate resistant prostate cancer (mCRPC)

Poster

Biomarkers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #97P

Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress

On October 9, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place from 19-23 October, in Munich, Germany (Press release, Hoffmann-La Roche, OCT 9, 2018, View Source [SID1234529810]). These data include positive Phase III results from Roche’s cancer immunotherapy development programme across multiple tumour types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumour-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumours.

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"We look forward to presenting the first positive Phase III study of a cancer immunotherapy combination in breast cancer, which showed encouraging results for Tecentriq plus nab-paclitaxel in people with metastatic triple-negative breast cancer, specifically in the PD-L1-positive population," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will also share new data from our pivotal analysis of entrectinib for people with NTRK gene fusion-positive solid tumours, an example of our continued commitment to developing next-generation personalised treatments."

An audio webcast for analysts and investors to discuss key data presented on the Roche Group’s oncology portfolio and pipeline during the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, will be held on Monday 22 October 2018 from 6:00 – 7:15 pm CEST. Further details are available here.

Follow Roche on Twitter via @Roche and keep up to date with ESMO (Free ESMO Whitepaper) 2018 Congress news and updates by using the hashtag #ESMO18.

Key Presentations
Breast cancer:
Primary results will be presented from the positive, Phase III, randomised IMpassion130 study investigating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), an aggressive type of the disease which currently has limited treatment options. Abstract LBA1_PR (Presidential Symposium 1) Saturday, 20 October, 16:30 -16:45 CEST: Hall A2 – Room 18

As reported earlier this year by Roche, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival (OS) improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.

Data from the IMpassion130 study will also be featured as part of ESMO (Free ESMO Whitepaper)’s press programme on Saturday, 20 October.

Tumour-agnostic:
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumours. Abstract LBA17 (oral) – Sunday, 21 October, 11:24 – 11:36 CEST: Hall B3 – Room 22

Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib. Roche is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalised healthcare solutions.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of NTRK gene 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.

Lung cancer:
Key data to be presented at ESMO (Free ESMO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.

OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC). Abstract LBA53 (oral) – Monday, 22 October, 09:15 – 09:30 CEST: Hall A1 – Room 17

PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomised, multicentre, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Abstract LBA10 (Presidential Symposium 3) – Monday, 22 October, 17:30-17:45 CEST: Hall A2 – Room 18

Liver cancer:
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin as treatment for patients with unresectable or advanced hepatocellular carcinoma (HCC). HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. Earlier this summer the US FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO (Free ESMO Whitepaper) include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease. Abstract LBA26 (oral) – Sunday, 21 October, 11:54 – 12:09 CEST: Hall A1 – Room17

Overview of key data featuring Roche medicines at ESMO (Free ESMO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies