On October 25, 2018 Novocure (NASDAQ: NVCR) reported financial results for the three and nine months ended September 30, 2018 (Press release, NovoCure, OCT 25, 2018, View Source [SID1234530195]). The company highlighted continued revenue growth supported by commercial momentum in newly diagnosed GBM and continued clinical development progress.

(1) An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.
(2) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

"We delivered record quarterly revenue of $64.8 million in the third quarter, representing 5% quarter-over-quarter growth, driven by both active patient growth and ongoing improvements in our gross-to-net spread," said Asaf Danziger, Novocure’s Chief Executive Officer. "Prescriptions for patients with newly diagnosed GBM continued to grow, reflecting increased demand from radiation oncologists and neurosurgeons in our global active markets. We also finalized a strategic collaboration with Zai Lab which enables commercial access to China and establishes a development partnership intended to progress Tumor Treating Fields in multiple solid tumor indications."

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"In September, we presented final data from our STELLAR trial and have now submitted an HDE application to the FDA in malignant pleural mesothelioma (MPM), which we believe brings us one step closer to our first indication outside of the brain," said William Doyle, Novocure’s Executive Chairman. "We continue to increase our investments in research and development with three ongoing phase 3 pivotal trials creating the potential for multiple interim or final data readouts within the next three years."

"Novocure is a global oncology company with a proprietary platform therapy, an established commercial business and significant upside potential from an advancing pipeline in multiple indications," continued Mr. Doyle. "With net cash flow from operating activities of $5.6 million during the quarter and more than $227 million in cash, cash equivalents and short-term investments on hand at the end of the third quarter, we believe we are in a position of strength to continue to execute our strategic plan."

Third quarter 2018 operating statistics and financial update

There were 2,252 active patients on Optune at September 30, 2018, representing 34 percent growth versus September 30, 2017, and 4 percent growth versus June 30, 2018. The increase in active patients was driven by increased commercial adoption and by continued growth in prescriptions for patients with newly diagnosed GBM, who typically have a longer duration of treatment with Optune.

In the United States, there were 1,602 active patients on Optune at September 30, 2018, representing 30 percent growth versus September 30, 2017.
In Germany and other EMEA markets, there were 581 active patients on Optune at September 30, 2018, representing 30 percent growth versus September 30, 2017.
In Japan, there were 69 active patients on Optune at September 30, 2018, representing 6,800 percent growth versus September 30, 2017.
Additionally, 1,243 prescriptions were received in the three months ended September 30, 2018, representing 16 percent growth compared to the same period in 2017, and flat versus the three months ended June 30, 2018. The year-over-year increase in prescriptions was driven primarily by commercial activities in the United States and Germany and Optune launch activities in Japan. We saw continued growth in prescriptions for newly diagnosed GBM with more than 930 Optune prescriptions in the third quarter, 75% of total prescriptions, written for patients with newly diagnosed GBM.

In the United States, 907 prescriptions were received in the three months ended September 30, 2018, representing 13 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 288 prescriptions were received in the three months ended September 30, 2018, representing 7 percent growth compared to the same period in 2017.
In Japan, 48 prescriptions were received in the three months ended September 30, 2018, representing 4,700 percent growth compared to the same period in 2017.
For the three months ended September 30, 2018, net revenues were $64.8 million, representing 29 percent growth versus the same period in 2017. Revenue growth was driven by increased Optune adoption in the United States and Germany and continuing launch activities in Japan, partially offset by the absence of one-time benefits from the 2017 cash to accrual revenue recognition transition.

For the three months ended September 30, 2018, cost of revenues was $18.9 million compared to $15.2 million for the same period in 2017, representing an increase of 25 percent. The increase was primarily driven by the cost of shipping transducer arrays to a higher volume of commercial patients, as well as an increase in field equipment depreciation.

Research, development and clinical trials expenses for the three months ended September 30, 2018, were $13.1 million compared to $9.3 million for the same period in 2017, representing an increase of 41 percent. This was primarily due to an increase in clinical trial and personnel expenses for our METIS, LUNAR, and PANOVA-3 trials and an increase in costs associated with medical affairs.

Sales and marketing expenses for the three months ended September 30, 2018, were $19.1 million compared to $16.4 million for the same period in 2017, representing an increase of 17 percent. This was primarily due to increases in our global sales force, increased marketing and market access expenses and increased facility expenses to support our geographical expansion in Japan and Austria.

General and administrative expenses for the three months ended September 30, 2018, were $18.9 million compared to $15.2 million for the same period in 2017, representing an increase of 24 percent. This was primarily due to an increase in share based compensation and an increase in professional services.

Personnel costs for the three months ended September 30, 2018, included $10.5 million in non-cash share-based compensation expenses, comprised of $0.5 million in cost of revenues; $1.2 million in research, development and clinical trials; $2.0 million in sales and marketing; and $6.8 million in general and administrative expenses. Total non-cash share-based compensation expenses for the third quarter 2017 were $8.6 million.

Net loss for the three months ended September 30, 2018, was $11.7 million compared to net loss of $11.5 million for the same period in 2017, representing a 2 percent decrease in net income.

At September 30, 2018, we had $123.0 million in cash and cash equivalents and $104.7 million in short-term investments, for a total balance of $227.7 million in cash, cash equivalents and short-term investments. This represents an increase of $8.7 million in cash and investments since June 30, 2018.

Anticipated clinical trial milestones

Initiation of phase 3 pivotal trial in recurrent ovarian cancer (Q4 2018)
First patient enrollment in phase 2 pilot HEPANOVA trial in advanced liver cancer (Q4 2018)
Final data collection from phase 3 pivotal METIS trial in brain metastases (2020)
Final data collection from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Final data collection from phase 3 pivotal PANOVA 3 trial in locally advanced pancreatic cancer (2022)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2018 financial results today, Thursday, October 25, 2018, at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2186119 .

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

On October 25, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reorted that highlighted multiple presentations evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) settings at the 11th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 27-29, 2018 (Press release, Seattle Genetics, OCT 25, 2018, View Source [SID1234530190]). Data include both encore and additional analyses from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline Stage III or IV classical HL adult patients, which formed the basis of U.S. Food and Drug Administration (FDA) approval in this indication in March 2018. Interim results will be presented from two ongoing clinical trials evaluating ADCETRIS in combination with Opdivo (nivolumab), including in newly diagnosed older HL patients. Lastly, five-year follow-up from the phase 3 AETHERA clinical trial will be presented. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor pathogenesis. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 50 ongoing clinical trials. ADCETRIS and Opdivo are not approved in combination for the treatment of HL.

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"After more than a decade of dedicated clinical research with ADCETRIS, we have made significant progress in improving the treatment outcomes for patients with Hodgkin lymphoma," said Nancy Whiting, Pharm.D., Senior Vice President, Clinical Development and Global Medical Affairs at Seattle Genetics. "At ISHL, we will present additional analyses from the ECHELON-1 trial, which demonstrated that ADCETRIS plus AVD improves upon a frontline standard of care regimen, ABVD, in advanced patients and resulted in the first change in advanced stage HL in over 40 years. In addition, three oral presentations will highlight ADCETRIS plus Opdivo combination data in frontline and relapsed/refractory HL and five-year data from the phase 3 AETHERA trial. We are pleased to share these results from our broad ADCETRIS clinical development program with the Hodgkin lymphoma community."

Multiple corporate presentations will be presented at ISHL. Abstracts will be available at www.hodgkinsymposium.org.

Data from four analyses of the phase 3 ECHELON-1 clinical trial will be presented at ISHL. Importantly, an analysis from the ECHELON-1 study (Abstract #0038) will be presented in an oral presentation and poster showing PFS data per investigator that is consistent with the previously reported modified PFS data per Independent Review Facility (IRF). The ECHELON-1 abstracts include the following:

Frontline brentuximab vedotin plus chemotherapy exhibits superior modified progression-free survival vs chemotherapy alone in patients with stage III or IV Hodgkin lymphoma: phase 3 ECHELON-1 study (Abstract #0038, oral presentation and poster on Monday, October 29 at 07:30-07:50 CEST)
Population pharmacokinetic modeling and exposure-response assessment of brentuximab vedotin efficacy and safety in patients with advanced classical Hodgkin lymphoma from the phase 3 ECHELON-1 study (Abstract #0137, poster presentation)
Serum sCD30 and TARC do not correlate with PET-based response assessment in patients (pts) with stage III or IV classical Hodgkin lymphoma (cHL): phase 3 ECHELON-1 study of brentuximab vedotin plus chemotherapy vs chemotherapy alone (Abstract #0159, poster presentation)
Brentuximab vedotin plus chemotherapy in high risk advanced-stage classical Hodgkin lymphoma (cHL) patients: Results of pre-specified sub-group analyses from the ECHELON-1 study (Abstract #0136, poster presentation)
Additional data presentations at ISHL include the following:

Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma: Follow-up Results from the Phase 1/2 Study (Abstract #0005, oral presentation on Monday, October 29 at 14:40-14:50 CEST)

Data will be reported from 62 patients with relapsed or refractory HL who received the combination regimen of ADCETRIS plus Opdivo after failure of frontline therapy. Patients were treated once every three weeks, with up to four cycles of combination therapy in the outpatient setting. After completion of the fourth cycle of treatment, patients were eligible to undergo an autologous stem cell transplant (ASCT). The median age of patients was 37 years. The majority of patients (95 percent) were refractory or had relapsed after receiving the standard of care frontline treatment ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or some variation of the standard of care (ABVE-PC, R-ABVD). Key findings will be presented in an oral presentation by Alex Herrera, M.D., Assistant Professor at the City of Hope Medical Center, Duarte, CA and include:

Of 61 response-evaluable patients, 49 patients (80 percent) had an objective response, including 37 patients (61 percent) with a complete response and 12 patients (20 percent) with a partial response.
Of the 61 response-evaluable patients, the estimated 21-month overall survival (OS) and PFS were 95 percent and 82 percent, respectively. The median follow-up time was 21.8 months and both median OS and PFS were not yet reached. Of 42 patients who underwent ASCT directly after treatment with ADCETRIS plus Opdivo, estimated PFS at 21-months was 97 percent and median PFS was not yet reached.
PFS was evaluated by response to treatment. The estimated PFS at 21-months for patients with a complete response was 97 percent, for patients with a partial response was 83 percent and patients with stable disease was 50 percent.
As previously reported, the most common adverse events (AEs) of any grade occurring prior to ASCT or subsequent salvage therapy in at least 20 percent of patients were nausea, infusion-related reaction (IRR), fatigue, pruritus, diarrhea, headache, vomiting, cough, pyrexia, dyspnea and nasal congestion.
Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥60 Years (Abstract #0153, oral presentation on Monday, October 29 at 15:05-15:15 CEST)

Interim results will be presented from an ongoing phase 2 clinical trial evaluating ADCETRIS in combination with Opdivo as frontline therapy for HL patients age 60 years or older. ADCETRIS combination data were reported from 14 patients. The median age of patients was 71.5 years. The majority of patients (79 percent) had stage III/IV disease at the time of diagnosis. The interim results will be highlighted in an oral presentation by Jonathan Friedberg, M.D., Director of the University of Rochester Medical Center, NY and include:

Of 11 response-evaluable patients with a median follow-up time of eight months, nine patients (82 percent) had an objective response, including six patients (55 percent) with a complete response and three patients (27 percent) with a partial response. In addition, two patients (18 percent) had stable disease which equates to all 11 patients (100 percent) experiencing disease control (complete response + partial response + stable disease) as a result of treatment with ADCETRIS in combination with Opdivo.
The most common AEs of any grade occurring in at least 25 percent of patients were fatigue, diarrhea, constipation, nausea, arthralgia, chills, decreased appetite, pyrexia, IRR, aspartate aminotransferase increased and peripheral sensory neuropathy. Grade 3 or higher adverse events occurred in seven patients (50 percent), and the most common were peripheral neuropathy and lipase increased (three patients each); nausea and alanine aminotransferase increased (two patients each).
Five patients (36 percent) had IRRs, with the majority of symptoms at Grade 1 and there were no Grade 3 or higher symptoms. Four patients (29 percent) were treated with corticosteroid and no patients discontinued treatment due to an IRR.
Five-Year Progression-Free Survival Outcomes from a Pivotal Phase 3 Study of Consolidative Brentuximab Vedotin after Autologous Stem-Cell Transplantation (ASCT) in Patients with Hodgkin Lymphoma at Risk of Relapse or Progression (AETHERA) (Abstract #0110, oral presentation on Monday, October 29 at 17:10-17:20 CEST)

The phase 3 AETHERA clinical trial was designed to evaluate the potential of single-agent ADCETRIS to extend PFS post-ASCT in patients with classical HL who were at high risk of relapse or progression. ADCETRIS was approved by the FDA in August 2015 for the treatment of adult patients with classical HL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The five-year follow-up efficacy and safety data will be highlighted in an oral presentation by Craig Moskowitz, M.D., Physician in Chief, Sylvester Comprehensive Cancer Center, University of Miami and include:

The five-year PFS rate per investigator was 59 percent in the ADCETRIS arm compared to 41 percent in the placebo arm. Median PFS per investigator was not yet reached in the ADCETRIS arm versus 15.8 months in the placebo arm. The hazard ratio was 0.521 indicating a 48 percent reduction in the risk of progression or death with treatment of ADCETRIS compared to placebo.
Fewer patients in the ADCETRIS arm of the study received subsequent anti-cancer therapies versus the placebo arm (32 percent versus 54 percent, respectively). In addition, fewer patients in the ADCETRIS arm received allogeneic stem-cell transplants versus the placebo arm (17 patients versus 31 patients).
A PFS analysis evaluating subgroups included patients in the ADCETRIS arm with either two or more or three or more risk factors, showed patients with a greater number of risk factors for relapse post-ASCT appeared to have the greatest benefit from ADCETRIS consolidation therapy. In both subgroups evaluating either two or more or three or more risk factors, median PFS was not reached in the ADCETRIS arm and was 9.7 months and 6.3 months, respectively, in the placebo arm.
In the ADCETRIS arm, 112 patients (67 percent) reported peripheral neuropathy. To date, 90 percent of these patients had resolution or improvement in symptoms, with 73 percent having complete resolution.
About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2018 and more than 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On October 25, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported it will provide an update on E2112, its NCI-sponsored, ECOG-ACRIN led pivotal trial of entinostat plus exemestane in hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer as well as its registration strategy for entinostat in combination with KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer (NSCLC), on Thursday, October 25 at 4:15 p.m. ET (Press release, Syndax, OCT 25, 2018, http://ir.syndax.com/news-releases/news-release-details/syndax-host-conference-call-provide-update-phase-3-breast-cancer [SID1234530187]).

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ECOG-ACRIN Cancer Research Group and the National Cancer Institute (NCI) informed the Company that enrollment has completed for E2112. The trial did not achieve the statistical hurdle for the first primary endpoint of improving progression-free survival (PFS) that would have provided the earliest regulatory filing opportunity. ECOG-ACRIN designed and is conducting E2112 to determine whether the addition of entinostat, a class I selective HDAC inhibitor, to exemestane, an aromatase inhibitor, improves PFS and overall survival (OS) in patients with HR+, HER2- breast cancer.

As planned, ECOG-ACRIN is confidentially holding the findings from the PFS analysis until reporting final OS results. After recently performing the third interim OS analysis, ECOG-ACRIN informed the Company that the trial will continue as planned until either it observes an OS benefit or the final target number of events occur. The next interim analysis for the OS primary endpoint is scheduled for 2Q19 with additional interim analyses every six months. Based on the trial design, any positive OS assessment would enable the Company to file for full regulatory approval.

"While the PFS analysis did not show a statistically significant benefit, E2112 was primarily designed to determine whether the combination of entinostat and exemestane could improve OS based on the compelling OS results obtained in the Phase 2b ENCORE 301 trial," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "It was Phase 2b OS results that led to the FDA granting Breakthrough Therapy Designation for this indication and we remain confident in the opportunity for a positive OS trial."

Update on entinostat registration plans in PD-1 / platinum pre-treated NSCLC patients

The Company also provided an update on its regulatory strategy for entinostat in combination with Merck’s anti-PD1 therapy, KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy.

The Company previously presented data from the Phase 2 ENCORE 601 NSCLC cohort that enrolled patients who received prior chemotherapy and anti-PD-(L)1 treatment, at the 2018 IASLC World Conference on Lung Cancer (WCLC) Annual Meeting this past September. Baseline peripheral classical monocyte data were available for 65 of the 72 NSCLC patients evaluable for efficacy and were divided into a group of high baseline monocytes ("monocyte high" n = 19) and low baseline monocytes ("monocyte low" n = 46). The monocyte high subset showed an improved benefit in median PFS (5.3 months vs 2.7 months), and an enhanced objective response rate (ORR, 21% vs 7%). The overall population demonstrated a 10% ORR (95% CI: 4-19%), median PFS of 2.8 months, and median duration of response of 5.3 months. The data also showed a manageable toxicity profile for the entinostat-pembrolizumab combination, with treatment emergent adverse events observed consistent with those previously reported.

"Patients whose disease has progressed despite treatment with PD-1 antagonists represent a very substantial unmet medical need, and efforts to identify novel biomarkers with clinical utility represent one of the most exciting areas of ongoing research," said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. "The proposed trial, which could both validate the use of classical monocytes as a selection criterion and establish the benefits of a new regimen over current standard of care, provides the opportunity for a significant advance for these patients."

The Company announced plans to initiate a randomized registration enabling trial comparing the entinostat-KEYTRUDA combination to standard of care chemotherapy in patients whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy. Following discussions with the U.S. Food and Drug Administration, the trial is designed to validate peripheral classical monocytes as a marker of response to the entinostat-KEYTRUDA combination and assess whether the combination is superior to standard of care chemotherapy in the high monocyte population. With PFS as the primary endpoint, the Company anticipates beginning the trial in the first half of 2019 and enrolling approximately 200 patients. The Company anticipates top-line data in the second half of 2020, which could lead to regulatory approval both in the U.S. and Europe. The trial will enroll patients with NSCLC whose tumors have progressed following treatment with a PD-1 antagonist and platinum-based chemotherapy.

Martin J. Edelman, Department Chair, Hematology/Oncology, Fox Chase Cancer Center, will join Syndax to discuss the findings from ENCORE 601 during the call at 4:15 p.m. Dr. Edelman is a nationally recognized expert in the treatment and research of lung cancer, and has focused on the development of new agents and biomarkers to personalize lung cancer therapy.

Conference Call and Webcast

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4088939
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

About Entinostat

Entinostat, a selective, oral, once-weekly inhibitor of class I histone deacetylases (HDACs), has been shown to resensitize Hormone Receptor positive (HR+) advanced breast cancer to endocrine therapy, and is currently being evaluated in a pivotal Phase 3 clinical trial in combination with exemestane for advanced HR+ breast cancer, an indication for which it has been granted Breakthrough Therapy Designation by the FDA. Entinostat has also been shown to block the function of immune suppressive cells in the tumor microenvironment, and is being evaluated in combination with several approved PD-1/PD-(L)1 antagonists, including in ongoing Phase 2 clinical trials combining entinostat with KEYTRUDA from Merck & Co., Inc. for non-small cell lung cancer, melanoma and colorectal cancer (ENCORE 601); with TECENTRIQ from Genentech, Inc. for triple negative breast cancer as well as advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer (ENCORE 602); and with BAVENCIO from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer (ENCORE 603).

About E2112

The E2112 trial (NCT0211528) is a randomized, double-blind, placebo-controlled Phase 3 trial of entinostat, Syndax’s Class I selective HDAC inhibitor, plus exemestane, an aromatase inhibitor, in patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have experienced disease progression following treatment with a non-steroidal aromatase inhibitor (NSAI). The trial, operating under a Special Protocol Assessment was designed, in collaboration with the NCI and ECOG-ACRIN Cancer Research Group, to have two primary endpoints, including progression-free survival and overall survival. The study enrolled a total of 605 patients randomized 1:1 across the two study arms. Syndax is providing the entinostat for the trial under a Cooperative Research and Development Agreement with the NCI.

On October 25, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its third quarter 2018 financial results on Thursday, November 1, 2018, after the close of the U.S. financial markets (Press release, CTI BioPharma, OCT 25, 2018, View Source;p=RssLanding&cat=news&id=2373419 [SID1234530179]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

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Thursday, November 1, 2018
1:30 p.m. PT/4:30 p.m. ET/10:30 p.m. CET
1-877-260-1479 (domestic)
+1 334-323-0522 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 4559931. The telephone replay will be available until Thursday, November 8, 2018.

On October 25, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the Third Quarter 2018 and provide a general business update before the U.S. markets open on Tuesday, November 6, 2018 (Press release, Adaptimmune, OCT 25, 2018, View Source;p=RssLanding&cat=news&id=2373619 [SID1234530172]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) on the same day.

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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 press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, please dial (833) 652-5917 (U.S.) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2458438).