On September 1, 2017 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported financial results for the six months ended June 30, 2017 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, SEP 1, 2017, View Source [SID1234520359]).

Clinical Development Program and Corporate Highlights Include:

Namodenoson (CF102): Progress in Clinical Development and Receipt of Milestone Payment

● Patient Enrollment Completed in Phase II Liver Cancer Trial of Namodenoson

Can-Fite enrolled and randomized all 78 patients for its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Patients with advanced HCC, Child Pugh B, were enrolled in the U.S., Europe and Israel. The primary endpoint of the Phase II study is overall survival. Can-Fite is following the survival data closely and plans to perform the survival analysis at the earliest possible opportunity. The HCC market is expected to generate $1.4 billion in sales in 2019.

● Milestone Payment Received for Distribution of Namodenoson in Korea for the Treatment of Liver Cancer

In August 2017, Can-Fite received a milestone payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD), which licensed the exclusive right to distribute Namodenoson for the treatment of liver cancer in Korea upon receipt of regulatory approvals. The payment is part of a deal worth up to $3,000,000 in upfront and milestone payments plus 23% royalties.

● Namodenoson to Commence Phase II Trial in the Treatment of NAFLD/NASH

During the second quarter of 2017, Can-Fite conducted a successful Clinical Investigator Meeting with principal investigators, researchers, and doctors participating as clinical investigators in the Company’s Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Namodenoson drug supply for the trial has been paid for and is ready to be administered to patients. The trial protocol has been approved by two leading Institutional Review Boards in Israel. Can-Fite estimates the cost of this Phase II trial to be less than $1 million. Patient enrollment is expected to begin in the third quarter of 2017. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

● Established Clinical Advisory Board for NASH Indication

Can-Fite established a Clinical Advisory Board comprised of Key Opinion Leaders to provide advice and steer Namodenoson’s clinical development program in the treatment of NAFLD and NASH. Board members include researchers and medical practitioners in the field of liver disease from institutions including Mount Sinai in New York, Virginia Commonwealth University School of Medicine, and Hadassah University in Israel.

Piclidenoson (CF101): ACRobat Phase III Trial in Rheumatoid Arthritis to Commence

In August 2017, Can-Fite successfully concluded a cardiodynamic trial for its lead drug candidate Piclidenoson, which showed favorable safety data required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) prior to initiation of Phase III studies.

During the second quarter of 2017, Can-Fite conducted a successful Clinical Investigator Meeting with approximately 100 rheumatologists, and their staff, who are participating as clinical investigators in the Company’s global pivotal Phase III ACRobat study, which is set to commence patient enrollment in the third quarter of 2017.

ACRobat is a Phase III trial that will evaluate Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The trial will enroll approximately 500 patients in Europe, Canada and Israel. The estimated cost of the entire Phase III study is approximately $5 million. Rheumatoid arthritis is a treatment market forecast to reach $34.6 billion by 2020.

Piclidenoson is also being developed as a treatment for psoriasis. Can-Fite is preparing for an upcoming Phase III trial that will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. Can-Fite expects to submit its clinical protocol to Institutional Review Boards in the fourth quarter of 2017. The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla sales are estimated to be $2.35 billion by 2020.

"Completion of patient enrollment in our Phase II study is a significant advancement in the development of Namodenoson to treat liver cancer. We will evaluate results as soon as possible based on survival data. There is a clear unmet medical need for HCC patients with Child-Pugh Class B cirrhosis. Our Orphan Drug status in both the U.S. and Europe, as well as Fast Track status in the U.S. in this indication, we believe will accelerate our path towards applying for market approval for Namodenoson for liver cancer," stated Can-Fite CEO Dr. Pnina Fishman. "In the current quarter, we look forward to commencing patient enrollment in our Phase II NAFLD/NASH study for Namodenoson and our Phase III rheumatoid arthritis study for Piclidenoson."

Financial Results

Revenues for the six months ended June 30, 2017 were NIS 0.53 million (U.S. $0.15 million) compared to NIS 0.43 million (U.S. $0.12 million) in the first six months of 2016. The increase in revenue was mainly due to the recognition of a portion of the NIS 1.9 million (U.S. $0.5 million) advance payment received in December 2016 under the distribution agreement with CKD.

Research and development expenses for the six months ended June 30, 2017 were NIS 8.84 million (U.S. $2.53 million) compared with NIS 9.97 million (U.S. $2.85 million) for the same period in 2016. Research and development expenses for the first half of 2017 comprised primarily of expenses associated with the Phase II study for Namodenoson, the preclinical study of CF602, as well as expenses for ongoing studies of Piclidenoson. The decrease is primarily due to a reduction in preclinical studies of CF602 conducted during the six months ended June 30, 2017.

General and administrative expenses were NIS 5.0 million (U.S. $1.43 million) for the six months ended June 30, 2017, the same as the general and administrative expenses for the same period in 2016.

Financial income, net for the six months ended June 30, 2017 aggregated NIS 1.57 million (U.S. $0.45 million) compared to financial income, net of NIS 3.19 million (U.S. $0.91 million) for the same period in 2016. The decrease in financial income, net in the first half of 2017 was mainly from exchange rate differences as compared to the same period in 2016 and from issuance expenses, offset by a larger decrease in the fair value of warrants that are accounted for as financial liability as compared to the same period in 2016.

Can-Fite’s net loss for the six months ended June 30, 2017 was NIS 11.72 million (U.S. $3.35 million) compared with a net loss of NIS 11.35 million (U.S. $3.25 million) for the same period in 2016. The slight increase in net loss for the first half of 2017 was primarily attributable to a decrease in financial income, net.

As of June 30, 2017, Can-Fite had cash and cash equivalents of NIS 23.98 million (U.S. $6.86 million) as compared to NIS 31.2 million (U.S. $8.92 million) at December 31, 2016. The decrease in cash during the six months ended June 30, 2017 is due to use of cash to fund operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on June 30, 2017 (U.S. $1 = NIS 3.496).

The Company’s consolidated financial results for the six months ended June 30, 2017 are presented in accordance with International Financial Reporting Standards.

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On August 31, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that it had been notified by its partner, Janssen Biotech, Inc., that Janssen is terminating the collaboration and license agreement with MacroGenics relating to duvortuxizumab, a CD19 x CD3 DART molecule (Press release, MacroGenics, AUG 31, 2017, View Source [SID1234520350]). Enrollment of the Phase 1 dose-escalation study of this molecule is being discontinued.

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Janssen reaffirmed its commitment to MGD015, also known as JNJ-9383, a second DART molecule licensed from MacroGenics. MGD015 is a preclinical program that targets CD3 and a non-disclosed cancer antigen expressed in hematological malignancies and lung cancer. Janssen has indicated that it anticipates initiating a first-in-human study with this molecule in 2018.

In the Phase 1 dose-escalation study of duvortuxizumab, multiple objective responses were observed in patients treated at various dosing levels tested. However, a number of patients experienced treatment-related neurotoxicity similar to that seen in patients treated with other CD19-targeted T-cell therapies. Given the recent advances in the highly competitive field for the treatment of B cell malignancies, the opportunity for development and commercialization has become less attractive.

"While this decision is disappointing, MacroGenics and its strategic partner, Janssen, continue to be fully committed to the DART platform and our ongoing collaboration on MGD015. Duvortuxizumab’s neurotoxicity profile is a CD19-targeting issue and has not been observed in our other DART clinical programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Given our large portfolio of product candidates currently being pursued, it is unlikely that we will continue development of this molecule at this time."

On September 31, 2017 AstraZeneca and MedImmune, its global biologics research and development arm, reported it will present results of more than 40 presentations, including two pivotal clinical trial readouts selected for late-breaking abstract presentation at the ESMO (Free ESMO Whitepaper) Presidential Symposia on Saturday, 9 September, which demonstrate significant improvements over current standard-of-care treatments in lung cancer:

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Results from the pivotal Phase III PACIFIC trial showing statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) following standard chemoradiation therapy, a clinical setting where there are currently no approved treatments (Press release, AstraZeneca, AUG 31, 2017, View Source [SID1234520360]).
Results of the Phase III FLAURA trial showing statistically-significant and clinically-meaningful PFS with Tagrisso (osimertinib) over current standard-of-care erlotinib or gefitinib as 1st-line treatments in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) NSCLC.
Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: "The superiority of 1st-line treatment with Tagrisso in the FLAURA trial and the potentially transformative Imfinzi data from the PACIFIC trial reinforce our significant contribution to advancing medicines for patients across multiple stages of lung cancer. We are also proud to share with the medical community our progress towards addressing the needs of patients with other types of difficult-to-treat tumours, including advanced ovarian, breast, and head and neck cancers."

Pushing the boundaries of lung cancer research

In addition to the two Presidential Symposia presentations, data being presented at ESMO (Free ESMO Whitepaper) demonstrate the breadth and depth of AstraZeneca’s commitment to advancing the treatment of lung cancer:

Overall survival data on Tagrisso from the Phase II AURA trials in patients with EGFR T790M mutation-positive advanced NSCLC (Abstract #1348P)
PFS data and central nervous system (CNS) responses to Tagrisso in patients with EGFR T790M NSCLC in the Asia Pacific region (AURA17) (Abstracts #1331P, 1353P and 1354P)
Established expertise in women’s cancers

Emerging data from studies of Lynparza, Faslodex, potential new medicines and combinations within women’s cancers will include:

Latest Phase III OlympiAD efficacy and health-related quality-of-life data for Lynparza vs. chemotherapy in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation (Abstract #243PD and 290P)
Phase III SOLO-2 data for Lynparza maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer (Abstract #932PD)
Sustained commitment in head and neck cancer

AstraZeneca is presenting additional evidence of the efficacy and safety of Imfinzi and the early potential of its combination strategy in head and neck cancer, including oral presentations on:

Preliminary data from the Phase II HAWK study of Imfinzi in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) (Abstract #1042O)
Safety, tolerability and anti-tumour activity in the Phase Ib/II SCORES study of Imfinzi in combination with STAT3 inhibitor AZD9150 or CXCR2 inhibitor AZD5069, in patients with HNSCC (Abstract #1049PD)

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at the ESMO (Free ESMO Whitepaper) 2017 Congress

Lead author

Abstract title

Presentation details

Lung cancer

Paz-Ares L
PACIFIC: A double-blind, placebo-controlled Phase III study of durvalumab after chemoradiation therapy (CRT) in patients with Stage III, locally advanced, unresectable NSCLC
Oral
Lung Cancer
Saturday 9th September, 16:30-18:10
Presentation Time: 16:30-16:45
Location: Madrid Auditorium
Abstract #LBA1

Ramalingam S
Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA)
Oral
Lung Cancer
Saturday 9th September, 16:30-18:10
Presentation Time: 17:30-17:45
Location: Madrid Auditorium
Abstract #LBA2

Zhou C
Detection of EGFR T790M in Asia-Pacific patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC): circulating tumour (ct) DNA analysis across 3 platforms
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1331P
Zhou C
Osimertinib in Asia-Pacific patients (pts) with EGFR T790M-positive advanced NSCLC: updated Phase II study results including progression-free survival (PFS)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #135P

Zhou C
CNS response to osimertinib in Asian-Pacific patients (pts) with T790M-positive advanced NSCLC: data from an open-label Phase II trial (AURA17)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1353P
Mitsudomi T
Overall survival (OS) in patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) treated with osimertinib: results from two Phase II studies
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1348P
Pinotti G
EGFR T790M detection in TKI-naïve NSCLCs carrying sensitive EGFR mutations
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1335P
Postel-Vinay S
A randomized double-blind Phase II trial evaluating maintenance PARP inhibitor Olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer: PIPSeN trial
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1381TiP
Kim Y C
Phase II Trial of AZD9291 in Second Line Treatment after Acquired Resistance with T790M Mutation Detected From Circulating Tumor DNA (LiquidLung-O-Cohort 2)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1360P
Calabuig-Farinas S
Clinical value of cfDNA and CTCs in EGFR mutations detected in advanced NSCLC
Poster
Lung Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #1638P
Leduc C
Ultrasensitive detection of EGFR T790M mutation by droplet digital PCR (ddPCR) in TKI naïve non-small cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide program Biomarkers France of the French Cooperative Thoracic Intergroup (IFCT)
Poster Discussion
Lung Cancer
Saturday 9th September, 9:00-10:45
Presentation Time: 10:16
Location: Pamplona Auditorium
Abstract #85PD
Wu Y-L
A Phase 3 study of first-line durvalumab vs platinum-based chemotherapy in patients with advanced NSCLC and high PD-L1 expression: PEARL
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1378TiP
Zhang X
Prediction of survival with durvalumab in locally advanced or metastatic NSCLC using early tumor assessments
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1312P

Women’s cancers

Martinez Bueno A
Disruptive mutations in TP53 associate with survival benefit in a PARPi trial in Ovarian Cancer
Oral
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Presentation Time: 09:15
Location: Cartagena Auditorium
Abstract #LBA42
Ruiz-Borrego M
Phase III evaluating the addition of fulvestrant (F) to Anastrozol (A) as adjuvant therapy in postmenopausal women with hormone receptor positive HER2 negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study
Oral
Breast Cancer
Friday 8th September, 14:00-15:30
Presentation Time: 14:24-14:36
Location: Pamplona Auditorium
Abstract #148O
Delaloge, S.
OlympiAD: Further efficacy outcomes in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice
Poster Discussion
Breast Cancer
Sunday 10th September, 09:15-10:45
Presentation Time: 09:45
Location: Sevilla Auditorium
Abstract #243PD
Wang J
FRIEND: A randomized pilot study to compare the efficacy and tolerability of fulvestrant 500mg with exemestane as first line endocrine therapy for post-m ER positive HER2 negative ABC patients relapse after adjuvant non-steroidal aromatase inhibitors (NSAI)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #311TiP

Kawaguchi H
Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer (JBCRG-C06; Safari): A subgroup analysis
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #302P
Kaufman P
Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer – an exploratory analysis of MONARCH 2
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #235P
Zimmer A
A Phase I PK/PD study of durvalumab (D) in combination with olaparib (O) and cediranib (C) in recurrent women’s cancers
Poster
Ovarian Cancer, Cervical, Breast, Endometrial
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #390P
Westin S
Phase I Expansion of olaparib (PARP inhibitor) and AZD5363 (AKT inhibitor) in recurrent ovarian, endometrial and triple negative breast cancer
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #391P
Turner N
BEECH: A randomised Phase 2 study assessing the efficacy of AKT inhibitor AZD5363 combined with paclitaxel in patients with ER+ve advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population
Poster Discussion
Breast Cancer
Sunday 10th September, 09:15-10:45
Presentation Time: 09:55
Location: Sevilla Auditorium
Abstract #241PD
Lui JF
A pilot study to evaluate the feasibility, usability, and perceived satisfaction with eCO (eCediranib-Olaparib), a mobile application for side effect monitoring and reporting, in women with recurrent ovarian cancer
Poster
Ovarian Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1560P
Nicum S
OCTOVA: A randomised Phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with BRCA-mutated platinum-resistant ovarian cancer
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #989TiP
Taylor J
N-DUR: Matched Pair Pharmacodynamics Study of Neoadjuvant Durvalumab in Combination with Chemotherapy in Frontline Ovarian Cancer
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #992TiP
Penson R
Efficacy of olaparib maintenance therapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by lines of prior chemotherapy: Phase III SOLO2 trial (ENGOT Ov-21)
Poster Discussion
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Presentation Time: 09:15
Location: Cartagena Auditorium
Abstract #932PD
Dalvi T
BREAKOUT: a cross-sectional, prospective, observational study of germline BRCA mutation (gBRCAm) prevalence and real-world outcomes among patients (pts) with HER2-negative (HER2-ve) metastatic breast cancer (mBC)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #316TiP
Shimomura A
Gene alteration in triple negative breast cancer patients in a phase I/II study of combination therapy with eribulin and olaparib
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #282P
Aogi K
Efficacy and safety of olaparib combined with eribulin in patients with advanced or metastatic triple negative breast cancer (TNBC) previously treated with anthracyclines and taxanes: the final analysis of a Japanese Phase I/II trial
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #251P
Robson ME
OlympiAD: Health-related quality of life (HRQoL) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm) receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice (TPC)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #290P

O’Connor M
Generation of a novel preclinical PK/PD model provides insights into PARP inhibitor clinical monotherapy activity
Poster
Women’s Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #393P
Tutt A
OlympiA: a randomized Phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #216TiP
Sugiyama T
Japan CHARLOTTE: Characterizing the cross-sectional approach to ovarian cancer: Genetic testing of BRCA
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #984TiP
Oza A
Evaluation of tumour responses and olaparib efficacy in platinum-sensitive relapsed ovarian cancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov-21)
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #965P
Callens C
BRCA1&2 tumoral and germline status for ovarian cancer patients in first line setting within the PAOLA-01 trial
Poster Discussion
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Location: Cartagena Auditorium
Abstract #935PD
Moore K
A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Poster
Ovarian Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #990TiP
Pjuade-Lauraine E
OReO/ENGOT Ov-38: A Phase IIIb trial of olaparib maintenance retreatment in patients with epithelial ovarian cancer
Poster
Ovarian Cancer
Saturday 9th September; 13:15-14:15
Location: Hall 8
Abstract #987TiP

Head and neck cancer

Cohen EE
Phase Ib/II Study (SCORES) Assessing Safety, Tolerability, and Preliminary Anti-tumor Activity of Durvalumab Plus AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Oral
Head and Neck Cancer
Monday 11th September, 11:00-12:30
Presentation Time: 11:15-11:30
Location: Madrid Auditorium
Abstract #1135O

Zandberg DP
Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, Phase II study
Oral
Head and Neck Cancer
Monday 11th September, 15:00-16:20
Presentation Time: 15:39-15:51
Location: Granada Auditorium
Abstract #1042O

Stokes M
Relationship between PD-L1 expression and survival in head and neck squamous cell carcinoma (HNSCC) patients (pts)
Poster Discussion
Head and Neck Cancer
Saturday 9th September, 14:45-16:15
Presentation Time: 15:07
Location: Alicante Auditorium
Abstract #1049PD
Pai S
Retrospective cohort study of PD-L1 expression in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SUPREME-HN)
Poster Discussion
Head and Neck Cancer
Saturday 9th September, 14:45-16:15
Presentation Time: 15:07
Location: Alicante Auditorium
Abstract #1048PD
Even C
MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination with Docetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN)
Poster
Head and Neck Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1109TiP

Other cancers

Choueiri T
Savolitinib versus sunitinib in patients with MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma: SAVOIR, a randomised, Phase III trial
Poster
Urothelial Carcinoma (UC)
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #924TiP
Zheng Y
Modeling of Tumor Kinetics and Overall Survival to Identify Predictive Factors for Efficacy of Durvalumab in Patients with Urothelial Carcinoma (UC)
Poster
Urothelial Carcinoma (UC)
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #869P
Gonzalez-Cao M
A Phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solid tumors
Poster
HIV
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1208TiP
Wiester T
Comparison of continuous measures across diagnostic PD-L1 assays using image analysis
Poster
Biomarker Testing
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #103P
Chen R
Efficacy and safety in first-line combined androgen blockade in advanced prostate cancer; a systematic review and meta-analysis
Poster
Prostate Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #805P

On August 30, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported positive topline data from its interim analysis of the ongoing, randomized Phase 2 trial evaluating CMB305 in combination with atezolizumab (TECENTRIQ) or atezolizumab alone in 88 soft tissue sarcoma patients (Press release, Immune Design, AUG 30, 2017, View Source [SID1234520357]). The data will be presented in a poster discussion session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, September 8-12, 2017 in Madrid, Spain.

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"The two main goals of this study are (1) to determine whether combining a next-generation vaccine like CMB305 with a checkpoint inhibitor (such as an anti-PD-L1 antibody) provides improved clinical benefit compared to that of the checkpoint inhibitor alone, particularly in a PD-L1-low or -negative tumor, and (2) in a randomized setting, to determine the biological activity of CMB305," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We believe these interim data constitute the first steps towards answering both questions in a favorable manner."

Data to be presented at ESMO (Free ESMO Whitepaper) build upon those data on the first 36 patients summarized in the abstract, and include a greater number of patients enrolled.

Clinical Benefit: Data from the larger patient population show that patients receiving CMB305 and atezolizumab experienced greater clinical benefit in the form of Disease Control Rate (including objective responses), Progression Free Survival and Time to Next Treatment than those receiving atezolizumab alone.
Immune Response: Patients who received the combination of CMB305 and atezolizumab demonstrated an increased frequency of induced immune responses to NY-ESO-1, including NY-ESO-1-specific T cells, NY-ESO-1 antibodies, and antigen spreading, in comparison to patients who received atezolizumab alone
Biomarkers: In an exploratory analysis, a trend towards improved overall survival was observed in patients in the CMB305 and atezolizumab combination arm who had pre-existing and treatment-induced anti-NY-ESO-1 immunity, compared to the atezolizumab alone arm. Pre-treatment tumor biopsy analysis showed negligible levels of PD-L1 expression.
Safety: No new safety signals have been observed in either arm.
The fully enrolled trial is evaluating the safety, immunogenicity and efficacy of CMB305 in combination with atezolizumab, or atezolizumab alone, in a total of 88 patients with locally advanced, relapsed, or metastatic NY-ESO-1+ synovial sarcoma or myxoid/round-cell liposarcoma. Atezolizumab is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1) and is being developed by Genentech, a member of the Roche Group. The trial is being conducted pursuant to a clinical collaboration with Genentech. Immune Design intends to present survival data in 2018 once all patients have at least one year of follow up (current data are preliminary: median duration of observation

The ESMO (Free ESMO Whitepaper) Poster Discussion session presentation details are as follows:

A Phase 2 Study of CMB305 and Atezolizumab in NY-ESO-1+ Soft Tissue Sarcoma: Interim Analysis of Immunogenicity, Tumor Control and Survival
Abstract # 1480PD
Session Title: Sarcoma Poster Discussion Session
Date: Monday, Sept. 11, 2017
Time: 11 a.m. — 12:30 p.m.
Location: Bilbao Auditorium
Poster Presenter: Dr. Sant Chawla
Poster Discussant: Dr. Robert Maki

About CMB305

CMB305 is a prime-boost vaccine approach against NY-ESO-1-expressing tumors, designed to generate an integrated, anti-NY-ESO-1 immune response in vivo via a targeted, specific interaction with dendritic cells, a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in soft tissue sarcoma patients in ongoing Phase 1 monotherapy and 2 combination studies. Immune Design has received Orphan Drug Designation for CMB305 from the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma, as well as from the FDA and European Medicines Agency for each of the components of CMB305 for the treatment of soft tissue sarcoma.

On August 30, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriah(TM)(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer (Press release, Novartis, AUG 30, 2017, View Source [SID1234520344]). Kymriah is the first therapy based on gene transfer approved by the FDA.

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"At Novartis, we have a long history of being at the forefront of transformative cancer treatment," said Joseph Jimenez, CEO of Novartis. "Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care."

"We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program," said Bruno Strigini, CEO of Novartis Oncology. "As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated."

The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for Kymriah. The REMS program serves to inform and educate healthcare professionals about the risks that may be associated with Kymriah treatment. To support safe patient access, Novartis is establishing a network of certified treatment centers throughout the country which will be fully trained on the use of Kymriah and appropriate patient care.

There has been an urgent need for novel treatment options that improve outcomes for patients with relapsed or refractory (r/r) B-cell precursor ALL, whose prognosis is poor. Patients often undergo multiple treatments including chemotherapy, radiation, targeted therapy or stem cell transplant, yet less than 10% of patients survive five years [2], [3].

Kymriah is an innovative immunocellular therapy that is a one-time treatment. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. In 2012, Novartis and the University of Pennsylvania (Penn) entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

"This therapy is a significant step forward in individualized cancer treatment that may have a tremendous impact on patients’ lives," said Carl June, MD, the Richard W. Vague Professor of Immunotherapy, Director of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine, who is a pioneer of this new treatment. "Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of hematologic and other cancer types."

In close collaboration with Novartis and Penn, Children’s Hospital of Philadelphia (CHOP) was the first institution to investigate Kymriah in the treatment of pediatric patients leading the single site trial.

"Tisagenlecleucel is the first CAR-T therapy to demonstrate early, deep and durable remission in children and young adults with relapsed or refractory B-cell ALL," said Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at Penn, and Director of the Cancer Immunotherapy Frontier Program at Children’s Hospital of Philadelphia (CHOP). "We’ve never seen anything like this before and I believe this therapy may become the new standard of care for this patient population."

Novartis is committed to ensuring eligible patients have access to Kymriah, and is working to ensure payers understand the value of Kymriah and provide coverage for patients. To address the unique aspects of the therapy, Novartis has also developed various patient access programs to support safe and timely access for patients. Novartis is also providing traditional support to patients by helping them navigate insurance coverage and providing financial assistance for those who are uninsured or underinsured.

Novartis plans additional filings for Kymriah in the US and EU later this year, including applications with the FDA and European Medicines Agency (EMA), for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL). Additional filings beyond the US and EU are anticipated in 2018.

Groundbreaking Collaboration with the Centers for Medicare and Medicaid Services
Novartis also announced a novel collaboration with the United States Centers for Medicare and Medicaid Services (CMS) focused on improving efficiencies in current regulatory requirements in order to deliver value-based care and ensure access for this specific patient population.

This approach is intended to include indication-based pricing for medicines and supports payments for a medicine, such as Kymriah for its initial indication, based on the clinical outcomes achieved, which would eliminate inefficiencies from the healthcare system. Other value-based approaches related to future indications for Kymriah and CAR-T cell therapies are under discussion.

Furthermore, Novartis is collaborating with CMS to make an outcomes-based approach available to allow for payment only when pediatric and young adult ALL patients respond to Kymriah by the end of the first month. Future potential indications would be reviewed for the most relevant outcomes-based approach.

"Novartis has been at the forefront of outcomes-based pricing and is very pleased to work with CMS on this first-of-its-kind collaboration with a technology that has the potential to transform cancer care," said Joseph Jimenez, CEO of Novartis. "We look forward to continuing to work with CMS to potentially expand this approach to other products and disease states."