On May 16, 2019 AstraZeneca reported that it will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 31 May to 4 June 2019 (Press release, AstraZeneca, MAY 16, 2019, View Source [SID1234536390]).

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In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers. Highlights include:

Late-breaking results from the Lynparza POLO trial, the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, a devastating diagnosis with critical unmet medical need. This is the first Phase III trial to validate a targeted treatment in a biomarker-selected population of pancreatic cancer.
Results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment. This data underscores Lynparza’s clinical benefit irrespective of line of treatment for women with BRCAm advanced ovarian cancer and the importance of knowing BRCA status at diagnosis.
Three-year overall survival (OS) data from the Phase III PACIFIC trial providing new evidence of the long-term survival benefit for Imfinzi in unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease had not progressed following chemoradiation therapy. Imfinzi is the only immunotherapy to demonstrate significant OS benefits in this curative-intent setting, and this data reaffirms the PACIFIC regimen as the standard of care for these patients.
Dave Fredrickson, Executive Vice President, Oncology, said: "AstraZeneca continues to break traditional treatment boundaries through new targeted approaches and the prioritisation of earlier intervention. This year at ASCO (Free ASCO Whitepaper), our data for Lynparza in BRCA-mutated metastatic pancreatic cancer and for Imfinzi in unresectable Stage III non-small cell lung cancer illustrate our ambition to change medical practice for better patient outcomes."

Breaking treatment boundaries

AstraZeneca is committed to redefining disease treatment for patient populations with unmet needs. This will be evidenced at the ASCO (Free ASCO Whitepaper) meeting for patients with PARP-mediated tumours, HER2-low expressing tumours, and AKT-mutated tumours.

The plenary presentation of results from the Phase III POLO trial will detail the progression-free survival (PFS) and important clinical benefit of Lynparza in patients with metastatic pancreatic cancer, a population that has seen very little treatment progress over the past 40 years (Abstract #LBA4).

New data on Lynparza will also be shared in advanced ovarian cancer, including the results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment (Abstract #5506).

Furthermore, the Phase II TOPARP-B trial, sponsored by the Institute of Cancer Research (UK), will highlight the anti-tumour activity of Lynparza in patients with heavily-pretreated metastatic castration-resistant prostate cancer with DDR gene defects (Abstract #5005). The Phase II GeparOLA trial, conducted by the German Breast Group and German AGO-B Breast Study Group, will help define the safety and efficacy of Lynparza, compared to platinum-based chemotherapy, in the neoadjuvant setting in HER2-negative early breast cancer and in patients with homologous recombination deficiency (Abstract #506).

The design of the Phase III DESTINY-Breast04 trial evaluating trastuzumab deruxtecan (DS-8201) in metastatic breast cancer with HER2-low expressing tumours will be presented at this year’s ASCO (Free ASCO Whitepaper) meeting (Abstract #TPS1102). The antibody drug conjugate (ADC) co-developed with Daiichi Sankyo has the potential to redefine breast cancer treatment. Two publications in Lancet Oncology recently highlighted the Phase I dose-expansion results for trastuzumab deruxtecan in HER2-positive metastatic breast and gastric cancers.

In addition, data will be presented from the Phase II FAKTION trial, sponsored by Velindre NHS Trust, on the combination of the AKT inhibitor capivasertib (AZD5363) plus Faslodex (fulvestrant) in patients with relapsed metastatic oestrogen receptor (ER)-positive breast cancer (Abstract #1005). AKT mutations occur across several different cancers and may be a target for treatment tailored to tumour genes rather than cancer types.

Treating patients earlier in their disease

AstraZeneca made a significant breakthrough in the treatment of NSCLC beginning in 2017 with the Phase III PACIFIC trial demonstrating unprecedented PFS and subsequently OS benefits for patients with unresectable, Stage III NSCLC treated with Imfinzi vs. standard of care. At this year’s ASCO (Free ASCO Whitepaper) meeting, AstraZeneca will provide new evidence of the long-term survival benefit of Imfinzi with a three-year OS update (Abstract #8526).

Sub-analysis presentations of Phase III data from SOLO-1, the only trial of a PARP inhibitor to demonstrate improvement in PFS for women with BRCAm advanced ovarian cancer as a 1st-line maintenance treatment, will reinforce the potential of using Lynparza earlier in the treatment pathway (Abstract #5539).

Raising the bar for better outcomes

New data from the Phase III FLAURA trial will explore clinical outcomes associated with the detection of epidermal growth factor receptor (EGFR) mutations in plasma at three or six weeks after starting treatment with Tagrisso (osimertinib) (Abstract #9020). With the presentation of the Phase II SAVANNAH trial design, AstraZeneca will explain how it will explore the combination of Tagrisso and savolitinib to potentially overcome MET-driven EGFR tyrosine kinase inhibitor (TKI) resistance following Tagrisso treatment in EGFR-mutated NSCLC (Abstract #TPS9119).

Despite recent therapeutic progress, platinum-resistant ovarian cancer remains a therapeutic challenge. Results of a multicenter, double-blind Phase II trial conducted by the Princess Margaret, California, Chicago and Mayo Phase II Consortia will show for the first time increased OS data with the Wee-1 inhibitor adavosertib when associated with the antimetabolite medicine gemcitabine (Abstract #5518).

A focus on haematology

The diverse haematology pipeline aims to deliver new medicines in a range of blood cancers with critical unmet medical need

AstraZeneca has established haematology as one of its key areas of focus. At the ASCO (Free ASCO Whitepaper) meeting and the upcoming 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), 13-16 June 2019, the Company will present long-term trial follow-up data showing the promising response rate, duration of response and safety profile of the Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL), including:

Three-year results from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL (Abstract #7500)
19-month results from the Phase II ACE-CL-208 trial of Calquence in patients with relapsed or refractory CLL intolerant to ibrutinib (Abstract #7530)
These data are part of a robust development programme that includes two pivotal clinical trials for Calquence in CLL with full data anticipated in 2019: the Phase III ASCEND (ACE-CL-309) trial in relapsed or refractory CLL, which recently met its primary endpoint, and the ongoing Phase III ELEVATE-TN (ACE-CL-007) trial evaluating Calquence with and without obinutuzumab in front-line CLL.

Key AstraZeneca presentations at ASCO (Free ASCO Whitepaper) 2019

Lead author

Abstract title

Presentation details

Immuno-Oncology

Gray, JE

Three-year overall survival update from the PACIFIC trial.

Abstract #8526

Poster Board #282

Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 2 June, 8:00-11:00am

Hall A

Planchard, D

First subsequent treatment after discontinuation of durvalumab in unresectable, Stage III NSCLC patients from PACIFIC.

Abstract #9054

Poster Board #377

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Rizvi, NA

Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic (m) NSCLC.

Abstract #9016

Poster Board #339

Poster Discussion – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 4:30-6:00pm

Hall D1

Garon, EB

Patient-reported outcomes (PROs) with first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic NSCLC: results from MYSTIC.

Abstract #9048

Poster Board #371

Poster Presentation – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Bradley, JD

PACIFIC-2: phase 3 study of concurrent durvalumab and platinum-based chemoradiotherapy in patients with unresectable, stage III NSCLC.

Abstract #TPS8573

Poster Board #327a

Poster Presentation – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 2 June, 8:00-11:00am

Hall A

DNA damage response

Kindler, H

Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial.

Abstract #LBA4

Plenary Session Including the Distinguished Achievement Award and Science of Oncology Award Lecture

Sunday 2 June, 3:15-3:30pm

Hall B1

Penson, R

Olaparib monotherapy versus (vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial.

Abstract #5506

Oral Abstract Session – Gynecologic Cancer

Monday 3 June, 3:15-3:27pm

S406

Colombo, N

Adverse events (AEs) with maintenance olaparib in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Phase III SOLO1 trial.

Abstract #5539

Poster Board #362

Poster Session – Gynecologic Cancer

Saturday 1 June, 1:15-4:15pm

Hall A

Mateo, J

TOPARP-B: A phase II randomized trial of the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib for metastatic castration resistant prostate cancers (mCRPC) with DNA damage repair (DDR) alterations.

Abstract #5005

Oral Abstract Session – Genitourinary (Prostate) Cancer

Friday 31 May, 4:09-4:21pm

Arie Crown Theater

Lheureux, S

A randomized double-blind placebo-controlled phase II trial comparing gemcitabine monotherapy to gemcitabine in combination with adavosertib in women with recurrent, platinum resistant epithelial ovarian cancer: A trial of the Princess Margaret, California, Chicago and Mayo Phase II Consortia.

Abstract #5518

Poster Board #341

Poster Session – Gynaecologic Cancer

Saturday 1 June, 4:30-6:00pm

Hall A

Fasching, P

GeparOLA: A randomized phase II trial to assess the efficacy of paclitaxel and olaparib in comparison to paclitaxel/carboplatin followed by epirubicin/cyclophosphamide as neoadjuvant chemotherapy in patients (pts) with HER2-negative early breast cancer (BC) and homologous recombination deficiency (HRD).

Abstract #506

Oral Abstract Session – Breast Cancer -Local/Regional/Adjuvant

Monday 3 June, 11:45-11:57pm

Hall D2

Tumour drivers and resistance

Oxnard, GR

SAVANNAH: A Phase II trial of osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-driven (MET+), locally advanced or metastatic non-small cell lung cancer (NSCLC), following disease progression on osimertinib.

Abstract #TPS9119

Poster Board #439b

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Zhou, C

Early clearance of plasma EGFR mutations as a predictor of response to osimertinib and comparator EGFR-TKIs in the FLAURA trial.

Abstract #9020

Poster Board #343

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Jones, RH

Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial.

Abstract #1005

Oral Abstract Session – Breast Cancer – Metastatic

Tuesday 4 June, 11:09-11:21am

Hall D1

Haematology

Woyach, J

Acalabrutinib with obinutuzumab (Ob) in treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Three-year follow-up.

Abstract #7500

Oral Abstract Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Tuesday 4 June, 9:45-9:57am

E451

Rogers, KA

Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Abstract #7530

Poster Board #284

Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Monday 3 June, 8:00-11:00am

Hall A

Trastuzumab deruxtecan (DS-8201)

Modi, S

A phase III, multicenter, randomized, open label trial of [fam-] trastuzumab deruxtecan (DS-8201a) versus investigator’s choice in HER2-low breast cancer.

Abstract #TPS1102

Poster Board #182a

Poster Session – Breast Cancer – Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

In addition to the scientific presentations and press releases planned at the ASCO (Free ASCO Whitepaper) meeting, AstraZeneca and its partner MSD (MSD: known as Merck & Co., Inc. inside the US and Canada) will host a press briefing on Sunday 2 June, on Lynparza. For more information, please contact AstraZeneca Global Media Relations.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On May 16, 2019 Geron Corporation (Nasdaq: GERN) reported that two abstracts containing clinical data and analyses related to imetelstat, the Company’s first-in-class telomerase inhibitor, have been accepted for presentation at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress to be held in Amsterdam, the Netherlands, from June 13-16, 2019 (Press release, Geron, MAY 16, 2019, View Source [SID1234536413]). The abstracts are available on the EHA (Free EHA Whitepaper) website at www.ehaweb.org/congress.

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"We appreciate the opportunity to present additional data and analyses at EHA (Free EHA Whitepaper) from the ongoing imetelstat clinical trials," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "In the Phase 2 portion of IMerge, the 8-week transfusion independence rate increased compared to the data presented last December, supporting the initiation of the Phase 3 portion of IMerge that we plan to open for screening and enrollment by mid-year 2019. For IMbark, the analyses reported in the abstract suggest that treatment with imetelstat is associated with a lower risk of death compared to best available therapy from closely matched real-world data from patients with Intermediate-2 or High-risk myelofibrosis after JAK inhibitor failure."

Updated Efficacy and Safety Data from the Phase 2 Portion of IMerge

Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

The abstract, accepted for an oral presentation, reports updated efficacy and safety data from 38 patients treated with imetelstat in Part 1 of IMerge, a Phase 2 clinical trial in transfusion dependent, non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to ESAs and naïve to hypomethylating agent (HMA) and lenalidomide treatment. The primary efficacy endpoint is 8-week RBC-TI rate, which is defined as the proportion of patients achieving red blood cell transfusion independence during any consecutive eight weeks since entry into the trial.

In the preliminary data set used to prepare the abstract, the 8-week RBC-TI rate was 45% (17/38). Based on the most recent clinical cut-off date, used to prepare the IMerge clinical data for the transition of the imetelstat program, the 8-week RBC-TI rate is 42% (16/38), which is an increase of two new responders compared to the 8-week RBC-TI rate of 37% (14/38) reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. The most frequently reported adverse events were manageable and reversible grade ≥3 cytopenias.

The abstract states these data support initiation of Part 2 of IMerge, the Phase 3 placebo-controlled trial, which is planned to be open for screening and enrollment by mid-year 2019.

Oral Presentation Details:
Session Title: Improvements in MDS Treatment
Session Date: Saturday, June 15
Session Time: 11:30 – 11:45 a.m. CET
Abstract Code: S837

The oral presentation is expected to provide more mature efficacy and safety data for the Phase 2 portion of IMerge.

Analysis of Overall Survival Data from IMbark

Abstract Title: Favorable Overall Survival of Imetelstat-Treated Relapsed/Refractory Myelofibrosis Patients Compared with Closely Matched Real World Data

This abstract, accepted for a poster presentation, provides a new analysis of the overall survival (OS) benefit in patients treated with imetelstat 9.4 mg/kg during the IMbark Phase 2 clinical trial, compared to real-world data (RWD) from patients who had discontinued from a JAK inhibitor (JAKi). For this analysis, historical RWD were collected from a single-center study of patients who had discontinued ruxolitinib. A closely matched cohort of these patients was identified using guidelines for inclusion and exclusion criteria as defined in the IMbark clinical protocol, and consisted of patients who had discontinued JAKi due to lack or loss of response and were subsequently treated with best available therapy (BAT) at the Moffitt Cancer Center. For comparability between the IMbark data and the RWD, several baseline clinical patient characteristics, such as, platelet count, spleen size, time from diagnosis to JAKi therapy discontinuation, MF type and others, were selected to assess the average treatment effect of imetelstat or BAT. Using propensity score approaches, median overall survival in the imetelstat-treated patients from IMbark was calculated to be 30.69 months compared to a median overall survival that was calculated to be 12.04 months in patients treated with BAT at the Moffitt Cancer Center (hazard ratio 0.35, p<.0019). These analyses suggest that treatment with imetelstat is associated with a lower risk of death compared to BAT from closely matched RWD from patients with Intermediate-2 or High-risk MF after JAKi failure.

Poster Presentation Details:
Session Title: Myeloproliferative neoplasms—Clinical
Session Date: Saturday, June 15
Session Time: 5:30 – 7:00 p.m. CET
Abstract Code: PS1456

In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the EHA (Free EHA Whitepaper) Annual Congress are embargoed from the time of submission. To be eligible for presentation at the EHA (Free EHA Whitepaper) Annual Congress, any additional data or information to be presented at the Annual Congress may not be made public before the presentation. The slide presentation and poster will be available at www.geron.com/r-d/publications following the EHA (Free EHA Whitepaper) Annual Congress presentations.

Post-EHA Event with Key Opinion Leaders

On June 25, 2019, Geron plans to host a webcasted event after the EHA (Free EHA Whitepaper) Annual Congress. At the event, authors from each of the imetelstat abstracts will reprise the respective presentations from the EHA (Free EHA Whitepaper) Annual Congress. A press release with event details, including how to access a webcast link, will be available on Geron’s website at the beginning of June.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial, called IMerge, in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial, called IMbark, in Intermediate-2 to High-risk myelofibrosis. Imetelstat received Fast Track designation from the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.

On May 16, 2019 Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported that an overview of the company’s business strategy and development-stage programs will be given at the 20th Annual B. Riley FBR Investor Conference being held in Beverly Hills, CA (Press release, Spectrum Pharmaceuticals, MAY 16, 2019, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-20th-annual-b [SID1234536429]). The company presentation is on Thursday, May 23, 2019, at 10:00 AM PDT.

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A live webcast of Spectrum’s presentation will be available at View Source

On May 16, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published an abstract on the Company’s clinical study evaluating its lead candidate, DPX-Survivac, in recurrent advanced ovarian cancer (Press release, IMV, MAY 16, 2019, View Source [SID1234536445]). The abstract was released online on the ASCO (Free ASCO Whitepaper) website yesterday in advance of ASCO (Free ASCO Whitepaper)’s annual meeting in Chicago, Illinois, taking place May 31 – June 4, 2019.

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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 final conference poster presentation will include additional data collected between the abstract submission cutoff date of February 12, 2019, and the presentation itself.

Conference Call and Webcast Information

IMV will host a webcast and conference call to provide an overview of its ASCO (Free ASCO Whitepaper) presentation on Sunday, June 2, 2019 at 9:00 a.m. ET. The conference line is (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International), and the conference ID# is 8579285. A live audio webcast and presentation will be available via this link and through the ‘Events and Presentations’ page of IMV’s website.

IMV ASCO (Free ASCO Whitepaper) 2019 Presentation Detail

Poster Title: "DPX-Survivac and intermittent low-dose cyclophosphamide (CPA) with or without epacadostat (E) in the treatment of subjects with advanced recurrent epithelial ovarian cancer (DeCidE1 trial): T cell responses and tumor infiltration correlate with tumor regression."
Abstract Number: 5576
Session Title: Gynecologic Cancer
Date and Time: June 1, 2019, 1:15 – 4:15 p.m. CT

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication. It is currently being evaluated in multiple Phase 1b/2 clinical trials.

On May 16, 2019 Novartis reported that it will present data from across its oncology portfolio at the upcoming 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 31-June 4 in Chicago; and the 24th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), scheduled for June 13-16 in Amsterdam (Press release, Novartis, MAY 16, 2019, View Source [SID1234536396]). The more than 100 abstracts to be presented underscore Novartis’ relentless commitment to addressing unmet needs in cancer and hematology through innovation and research. Data will focus on a range of disease areas, including breast cancer, lung cancer, melanoma and sickle cell disease, as well as leukemias, other hematologic disorders and solid tumors.

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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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"We are excited to share the latest information about our transformative therapies in cancer and serious blood disorders at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this year," said Susanne Schaffert, CEO, Novartis Oncology. "New data will showcase our scientific and patient-focused prowess across a range of the most difficult-to-treat diseases in the world."

Novartis data at the 2019 ASCO (Free ASCO Whitepaper) Annual Congress will highlight the following:

Kisqali overall survival results, and additional data on treatment sequencing and patient reported outcomes in HR+/HER2- advanced breast cancer:

Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results [Abstract # LBA1008; Oral presentation: Tuesday, June 4, 11:57 AM CDT]
Interim results in the full population from CompLEEment-1, a phase 3b study of ribociclib and letrozole as first-line therapy for advanced breast cancer in an expanded population [Abstract #1041; Sunday, June 2, 8:00 AM CDT]
Alpelisib (ALP) + endocrine therapy (ET) in patients with PIK3CA-mutated hormone-receptor positive (HR+), human epidermal growth factor-2-negative (HER2-) advanced breast cancer (ABC): First interim BYLieve results [Abstract #1040; Sunday, June 2, 8:00 AM CDT]
Patient-reported outcomes (PROs) in patients with PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) from SOLAR-1 [Abstract #1039; Sunday, June 2, 8:00 AM CDT]
Alpelisib (ALP) + fulvestrant (FUL) in patients with PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC): SOLAR-1 results by therapy line and endocrine therapy resistance (ETR) [Abstract #1038; Sunday, June 2, 8:00 AM CDT]
NATALEE: Phase 3 study of ribociclib (RIBO) + endocrine therapy (ET) as adjuvant treatment in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) [Abstract #TPS597; Sunday, June 2, 8:00 AM CDT]
First-line ribociclib plus letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): MONALEESA-2 long-term safety results [Abstract #1078; Sunday, June 2, 8:00 AM CDT]
Continuous dosing ribociclib, everolimus, exemestane in HR+ and HER2- advanced breast cancer post-progression on a CDK4/6 inhibitor [Abstract #1016; Sunday, June 2, 8:00 AM CDT, Poster discussion: 11:15 AM CDT]
In-depth gene expression analysis of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib containing therapy in the Phase III MONALEESA-7 trial [Abstract #1018; Sunday, June 2, 11:15 AM CDT, Poster discussion: 11:30 AM CDT]
Long-term and new analyses of the Tafinlar+Mekinist COMBI trials in melanoma:

Five-year analysis of dabrafenib plus trametinib (D+T) in patients with BRAF V600-mutant unresectable or metastatic melanoma confirms long-term benefit [Abstract #9507; Oral presentation: Tuesday, June 4, 11:57 AM CDT]
The anti-PD-1 antibody spartalizumab (S) in combination with dabrafenib (D) and trametinib (T) in previously untreated patients with advanced BRAF V600-mutant melanoma: updated efficacy and safety from parts 1 and 2 of COMBI-i [Abstract #9531; Monday, June 3, 1:15 PM CDT]
Circulating tumor DNA (ctDNA) kinetics to predict survival in patients with unresectable or metastatic melanoma treated with dabrafenib (D) or D + trametinib (T) [Abstract #9510; Oral presentation: Saturday, June 1, 3:24 PM CDT]
Tumor microenvironment (TME), longitudinal biomarker changes, and clinical outcome in patients with advanced BRAF V600-mutant melanoma treated with 1st-line spartalizumab (S) + dabrafenib (D) + trametinib (T) [Abstract #9515; Monday, June 3, 1:15 PM CDT; Poster discussion: 4:30 PM CDT]
Association between baseline disease characteristics and relapse-free survival (RFS) in patients with BRAF V600-mutant resected stage III melanoma treated with adjuvant dabrafenib (D) + trametinib (T) or placebo (PBO) [Abstract #9582; Monday, June 3, 1:15 PM CDT]
Results from GEOMETRY study investigating capmatinib (INC280) in NSCLC:

Capmatinib (INC280) in METVAR.ex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study [Abstract #9004; Oral presentation: Monday, June 3, 9:12 AM CDT]
Analyses on treatment of advanced solid tumors and hematologic malignancies with spartalizumab (PDR001) in combination with other agents:

Phase Ib study of MIW815 (ADU-S100) in combination with spartalizumab (PDR001) in patients with advanced/metastatic solid tumors or lymphoma [Abstract #2507; Oral presentation: Sunday, June 2, 10:12 AM CDT]
Phase II, open-label study of spartalizumab (PDR001) and LAG525 for patients with advanced solid tumors and hematologic malignancies [Abstract #2553; Saturday, June 1, 8:00 AM CDT]
A study evaluating Kymriah (tisagenlecleucel)*** in follicular lymphoma:

ELARA: A Phase 2, single-arm, multicenter, open-label trial investigating the efficacy and safety of tisagenlecleucel in adult patients with refractory/relapsed follicular lymphoma (r/r FL) [Abstract #TPS7573; Monday, June 3, 8:00 AM CDT]
Long-term treatment-free remission (TFR) data, after Tasigna treatment discontinuation, in patients with CML:

ENESTop 192-week results: treatment-free remission (TFR) in patients with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib (NIL) [Abstract #7005; Oral presentation: Saturday, June 1, 4:24 PM CDT]
Treatment-free remission (TFR) following frontline (1L) nilotinib (NIL) in patients with chronic myeloid leukemia in chronic phase (CML-CP): 192-week data from the ENESTfreedom study [Abstract #7013; Monday, June 3, 1:15 PM CDT, Poster discussion: 4:30 PM CDT]
Additional data presented at ASCO (Free ASCO Whitepaper) include:

The CANOPY Program: Canakinumab in patients with non-small cell lung cancer (NSCLC) [Abstract #TPS9124; Sunday, June 2, 8:00 AM CDT]
CANOPY-A: A Phase 3 study of canakinumab as adjuvant therapy in patients with surgically resected non-small cell lung cancer (NSCLC) [Abstract #7013; Sunday, June 2, 8:00 AM CDT]
Advanced Accelerator Applications, a Novartis company and leader in nuclear medicine theragnostics, will present additional analyses from the NETTER-1 study evaluating Lutathera (lutetium Lu 177 dotatate)**** in patients with progressive midgut neuroendocrine tumors:

Analyses of patient diaries in the NETTER-1 study of 177Lu-DOTATATE versus high-dose octreotide in progressive midgut neuroendocrine tumors [Abstract #4111; Monday, June 3, 8:00 AM CDT]
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present data for the company’s biosimilar pegfilgrastim:

Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (febrile) neutropenia and expanded access based on budget neutral basis [Abstract #6645; Saturday, June 1, 1:15 PM CDT]
Additional data from Sandoz to be featured online by ASCO (Free ASCO Whitepaper) include:

A large multi-center, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with EU and US reference pegfilgrastim [online only]
Novartis data at the 2019 EHA (Free EHA Whitepaper) Annual Congress will highlight the following:

Retrospective data for investigational compound crizanlizumab (SEG101):

SUCCESSOR: A multicenter retrospective non-interventional follow-up study in patients with sickle cell pain crises who previously participated in the SUSTAIN trial in the United States SUCCESSOR study [Abstract #S853; Oral presentation: Saturday, June 15, 11:45 AM CET]
Expert consensus paper on tapering and discontinuation of TPO-RAs and additional results of worldwide ITP impact survey:

Tapering and discontinuation of thrombopoietin receptor agonists in ITP: Expert consensus opinions [Abstract #PF709; Friday, June 14, 5:30 PM CET]
Physicians’ perceptions on causes of primary and secondary ITP and leading causes of misdiagnosis: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF712; Friday, June 14, 5:30 PM CET]
Patient perceptions on splenectomy outcomes: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF714; Friday, June 14, 5:30 PM CET]
Differences on perceptions on treatment approaches between physicians and ITP patients: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF711; Friday, June 14, 5:30 PM CET]
Data on the investigational compound asciminib (ABL001) in combination with other tyrosine kinase inhibitors in previously treated CML patients:

Combination therapy using asciminib plus imatinib (IMA) in patients with chronic myeloid leukemia (CML): Results from a Phase 1 study [Abstract #S883; Oral presentation: Saturday, June 15, 4:30 PM CET]
Combination of asciminib plus nilotinib (NIL) or dasatinib (DAS) in patients with chronic myeloid leukemia: Results from a Phase 1 study [Abstract #S884; Oral presentation: June 15, 4:30 PM CET]
Data analyses with a 3.7-year follow-up for Tasigna TFR in CML:

Durability and impact on quality of life of treatment-free remission (TFR) in patients with chronic myeloid leukemia after stopping frontline (1L) nilotinib: [Abstract #PF409; Friday, June 14, 5:30 PM CET]
ENESTop 192-week results: Durability and impact on quality of life of TFR second-line (2L) nilotinib [Abstract #PF411; Friday, June 14, 5:30 PM CET]
Abstracts analyzing the safety and efficacy of Kymriah in acute lymphoblastic leukemia, and on regrading of adverse events in diffuse large B-cell lymphoma:

Tisagenlecleucel appears effective and safe in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia with high-risk cytogenetic abnormalities [Abstract #S1618; Oral presentation: Sunday, June 16, 8:15 AM CET]
Analyses of cytokine release syndrome and neurotoxicity by age and lymphodepleting chemotherapy use in adults with relapsed or refractory diffuse large B-cell lymphoma treated with tisagenlecleucel [Abstract #PF305; Friday, June 14, 5:30 PM CET]
Safety and efficacy of Jakavi (ruxolitinib)***** in myelofibrosis (MF) and anemia, and additional results from a large-scale survey on the impact of myeloproliferative neoplasms:

Safety and efficacy of ruxolitinib (RUX) in patients with myelofibrosis (MF) and anemia (HB <10 g/dl): Results at week 24 of the REALISE trial [Abstract #PS1465; Saturday, June 15, 5:30 PM CET]
Impact of myeloproliferative neoplasms (MPNs) and perceptions of treatment goals amongst physicians and patients in 6 countries: An expansion of the MPN Landmark Survey [Abstract #PF681; Friday, June 14, 5:30 PM CET]
New and updated data evaluating the efficacy and safety of Rydapt (midostaurin) in patients with acute myeloid leukemia (AML) and different genetic mutational status:

RATIFY post-hoc analyses:
Prognostic and predictive impact of NPM1/FLT3-ITD genotypes as defined by 2017 European LeukemiaNet (ELN) risk categorization from randomized patients with acute myeloid leukemia (AML) treated within the international RATIFY Study (ALLIANCE 10603) [Abstract #PF260; Friday, June 14, 5:30 PM CET]
Genetic landscape of FLT3-mutated acute myeloid leukemia (AML) patients treated within the RATIFY Trial: CALGB 10603 (ALLIANCE) [Abstract #PS968; Saturday, June 15, 5:30 PM CET]
RATIFY: Prognostic impact of FLT3 tyrosine kinase domain (TKD) and NPM1 mutation status in patients with newly diagnosed acute myeloid leukemia (AML) treated with midostaurin + standard chemotherapy [Abstract #PF256; Friday, June 14, 5:30 PM CET]
Throughout the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting and EHA (Free EHA Whitepaper) Annual Meeting, Novartis will host dedicated content on Twitter, Facebook, and LinkedIn, featuring leader and patient insights and perspectives on the emerging trends in cancer care and research.

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