On December 7, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that tucatinib in combination with standard of care agents demonstrated prolonged progression-free survival (PFS) in a subgroup of patients participating in two ongoing Phase 1b studies (Press release, Cascadian Therapeutics, DEC 7, 2017, View Source [SID1234522438]). Results from a subgroup analysis from these tucatinib combination studies showed 22 percent of patients with HER2-positive (HER2+) metastatic breast cancer with and without brain metastases achieved prolonged PFS defined as twice the median PFS seen in these studies or else defined as survival greater than 17 months. Patients received a median of two prior HER2-based regimens and the median duration of the last prior treatment in this subgroup was 9.03 months. Patients with prolonged PFS on tucatinib combination therapy included those with characteristics that historically predict poor outcome such as hormone receptor status, presence of visceral disease, burden of systemic or brain disease and age. Results from this analysis will be presented in a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS) on Friday, December 8, 2017 beginning at 5:00 p.m. CST.

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"One of the challenges in the treatment of HER2+ breast cancer is the frequent development of brain metastases, which occur in up to 50 percent of patients with advanced disease," said Erika Hamilton, M.D., Director of Breast and Gynecology Cancer Research and Principal Investigator at Sarah Cannon Research Institute. "Tucatinib in combination has shown early signs of activity in HER2+ brain metastases. An active agent showing prolonged activity systemically as well as in the brain, with a tolerable safety profile, would represent a meaningful advancement in treating metastatic breast cancer."

Dr. Hamilton continued, "The more mature dataset from these Phase 1b combination studies show tucatinib may be combined with other standard targeted therapies to achieve disease control in patients who have received multiple prior lines of therapy."

Prolonged Progression-Free Survival in Advanced HER2+ Metastatic Breast Cancer with or without Brain Metastases: A Pooled Analysis of Tucatinib Phase 1b Studies

In this poster, data from two Phase 1b combination studies of tucatinib were pooled to analyze the subgroup of patients with prolonged PFS, which was identified as patients achieving at least twice the observed median PFS in the overall group. Baseline characteristics and radiology findings were compared between the subgroup of patients with or without prolonged PFS from two studies: tucatinib in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) in heavily pre-treated patients with advanced HER2+ breast cancer with or without brain metastases (ONT-380-005/Triplet study; n=27), and tucatinib in combination with T-DM1 (ONT-380-004; n=50). Of the 77 patients in the pooled analysis, 47 percent (n=36) of patients are without brain metastases and 53 percent (n=41) are with brain metastases, including patients with untreated or progressive brain metastases after radiation therapy. Twenty-two percent (17/77) of patients demonstrated prolonged PFS; 20 percent (n=10/50) from Study 004 and 26 percent (n=7/27) from Study 005/Triplet. Data from pooled tucatinib studies suggest a similar proportion of patients with brain metastases in the subgroup of patients with prolonged PFS compared to the overall patient population.

In addition, the following investigator-initiated trial in progress poster was presented at SABCS.

Phase 1b/2 Open-Label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination with Letrozole and Palbociclib in Subjects with Hormone Receptor Positive and HER2 Positive Metastatic Breast Cancer (TULiP Trial)

The University of Colorado Cancer Center presented a trials in progress poster summarizing the study design for the ongoing TULiP trial in patients with hormone receptor positive and HER2-positive (HR+/HER2+) metastatic breast cancer. In this study, tucatinib, a highly selective inhibitor of HER2 tyrosine kinase, is combined with an aromatase inhibitor letrozole and CDK4/6 inhibitor palbociclib. The TULiP study is expecting to enroll 40 patients. It is currently opened for enrollment at the University of Colorado Denver, and soon will be opened at five additional academic institutions (members of Academic Breast Cancer Research Consortium): North Western University, Chicago, IL; University of Texas Health and Science Center at San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ, and University of New Mexico, Albuquerque, NM. The Phase 1b part of the trial is expected to enroll 20 patients and will evaluate the tolerability of tucatinib given at maximum tolerated dose (300mg by mouth twice a day) with the standard doses of palbociclib and letrozole. The Phase 2 part of the trial is expected to enroll 20 additional patients to enable analysis of efficacy by overall response rate and progression-free survival. Because of documented activity of tucatinib in the CNS disease, the TULiP trial will include patients with brain metastases. For more information, visit ClinicalTrials.gov, Identifier: NCT03054363.

"Finding novel treatments for HR+/HER2+ breast cancers remains an area of unmet clinical need, because of intrinsic resistance of these tumors to both anti-hormonal treatments and HER2-targeted agents," said Elena Shagisultanova, MD, PhD, Assistant Professor at the University of Colorado Denver Cancer Center and Lead Principal Investigator of TULiP trial. "We are very excited about the TULiP trial. There is significant preclinical evidence on synergistic anti-tumor activity of CDK4/6 inhibitors and HER2-targeted agents. Tucatinib, palbociclib and letrozole have largely non-overlapping toxicity profiles and metabolic pathways. We believe that this triple combination of targeted agents will be well tolerated and highly patient centered, as an effective non-chemotherapy based regimen for treatment of patients with HR+/HER2+ metastatic breast cancer. We are grateful for the support we received from both Cascadian Therapeutics and Pfizer while working on this trial."

To access these poster presentations, please visit www.cascadianrx.com.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without inhibition of EGFR. Inhibition of EGFR has been associated with clinical toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 (HER2+) are more aggressive and historically have been associated with poor overall survival, compared with HER2-negative cancers.

About HER2CLIMB Pivotal Trial

HER2CLIMB is a randomized (2:1), double-blind, placebo-controlled pivotal clinical trial comparing tucatinib vs. placebo, each in combination with capecitabine and trastuzumab and without loperamide or budesonide prophylaxis, in patients with locally advanced or metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine, also known as T-DM1. The primary endpoint is progression-free survival (PFS) based upon independent radiologic review. Key objectives related to assessing activity in brain metastases include a key secondary endpoint of PFS in a subset of patients with brain metastases. All patients will be followed for overall survival. HER2CLIMB is currently enrolling patients in the United States, Canada, Western Europe and Australia. Additional information is available at www.HER2CLIMB.com.

About HER2+ Metastatic Breast Cancer

Patients with HER2+ breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. The American Cancer Society estimates that 20-25 percent of the approximately 246,660 annual new cases of breast cancer diagnoses in the U.S. are HER2+. Historically, HER2 disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Up to 50 percent of patients with HER2+ metastatic breast cancer experience brain metastases over time.3 Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib, and T-DM1) have led to improved time to progression and survival rates of patients with HER2+ breast cancer. Despite these advances, there is still a significant need for new therapies that can impact metastatic disease, including brain metastases, and be tolerated for longer periods of time.

On December 7, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported that new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial in advanced solid tumors, demonstrate anti-tumor activity across a broad panel of breast cancer cell lines and point to potential biomarkers predictive of response (Press release, Syros Pharmaceuticals, DEC 7, 2017, View Source [SID1234522431]). The Company also announced its identification of key genes driving relapse and metastasis in triple negative breast cancer (TNBC), pointing to potential new drug targets. These data were presented at the San Antonio Breast Cancer Symposium (SABCS).

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"These data speak to the power of our gene control platform to provide a new lens for understanding disease with important implications for developing much-needed therapies in defined subsets of patients," Eric R. Olson, Ph.D., Chief Scientific Officer of Syros. "Despite advances in the treatment of certain cancers, two of the biggest challenges in cancer treatment remain the ability to pair the right patients with the right drugs and to prevent the emergence of drug resistance in response to targeted therapies. By analyzing regulatory regions of the genome, we discovered potential biomarkers of response to SY-1365 within heterogeneous patient populations that we can further explore during clinical development. Separately, using our platform, we also identified new potential points of therapeutic intervention in TNBC with the potential to thwart the mechanisms cancer uses to become resistant to therapy and spread to other parts of the body."

New Preclinical Data on SY-1365
Syros scientists analyzed the anti-tumor activity of SY-1365 across a panel of more than 400 cancer cell lines, including 19 TNBC cell lines and 21 ER-positive, PR-positive and HER2-positive cells lines. They then grouped the cell lines according to sensitivity to SY-1365 and looked for markers of response using Syros’ gene control platform to analyze regulatory regions of the genome. The data showed:

SY-1365 induced cell death in 15 out of the 19 TNBC cell lines and 17 of the 21 ER-positive, PR-positive and HER2-positive cells lines.
Sensitivity to SY-1365 in these breast cancer cell lines was associated with a super-enhancer, a highly specialized regulatory region of the genome, that drives increased expression of the known oncogene MYC.
Sensitivity to SY-1365 was also associated with low expression of the mitochondrial apoptosis antagonist BCL2L1 in these cell lines.
Lowered expression of MCL1, a gene in the mitochondrial apoptosis pathway known to inhibit apoptosis, was associated with SY-1365 target engagement and anti-tumor activity in cell lines and a cell-derived xenograft model of TNBC.
The Phase 1 trial of SY-1365 is a multi-center, open-label trial enrolling patients with advanced solid tumors. The primary objective of the trial is to assess the safety and tolerability of escalating doses of SY-1365, with the goal of establishing a maximum tolerated dose and a recommended Phase 2 dose and regimen. The dose-escalation phase is open and expected to enroll approximately 35 solid tumor patients for whom standard curative or palliative measures do not exist or are no longer effective. Following the dose-escalation phase, expansion cohorts are planned to further evaluate the safety and anti-tumor activity of SY-1365 in patients with transcriptionally driven tumors and to enroll patients with tumors of any histology in a cohort focused on analyzing biopsied tumor tissue. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov. Syros expects to present initial clinical data from this study in 2018.

Mechanisms of Relapse and Metastasis in TNBC
Using its gene control platform, Syros scientists, in collaboration with the lab of Robert Weinberg, Ph.D. at the Whitehead Institute, analyzed regulatory regions of the genome in cancer-stem cell enriched TNBC cell lines. Cancer stem cells (CSCs) are known to be involved in resistance to chemotherapies, relapse of disease and development of metastasis. The analysis revealed key genes that may be involved in driving disease relapse and metastasis, with implications for the discovery and development of novel therapies for TNBC. Notably, TP73 was found to be a core driver of transcriptional circuitry in CSCs, controlling super-enhancer associated genes involved in cell migration, signal transduction and developmental processes. TP73 is a gene that encodes a DNA-binding transcription factor called p73. The set of TP73-controlled genes provide new leads for drug discovery and development with potential to yield much-needed new therapies for TNBC patients.

On December 7, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) reported updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer (TNBC) at the 2017 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2017 (Press release, Seattle Genetics, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321594 [SID1234522430]). Ladiratuzumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E (MMAE), to cancer cells which express the protein LIV-1. LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.

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"Overall, the phase 1 results we’ve presented at SABCS confirm previous findings that single-agent treatment with ladiratuzumab vedotin was generally well-tolerated and showed encouraging antitumor activity in patients with heavily-pretreated metastatic TNBC," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "We continue to evaluate ladiratuzumab vedotin monotherapy in TNBC, with planned combination studies in earlier lines of treatment, demonstrating our overarching commitment to improve the health of women with this devastating disease."

Findings from this ongoing phase 1 study of ladiratuzumab vedotin in patients with metastatic breast cancer were last presented at the 2016 SABCS. The updated results presented today in a spotlight session describe the safety, tolerability, and antitumor activity of ladiratuzumab vedotin in 28 additional patients with TNBC.

Phase 1 Study of the Antibody-Drug Conjugate Ladiratuzumab Vedotin (SGN-LIV1A) in Patients with Heavily Pretreated Triple-Negative Metastatic Breast Cancer (Poster# PD3-14, Poster Session – Novel Drugs / Predicting Response for HER2+ Breast Cancer at 7:00 – 9:00 a.m. CT on Thursday, December 7, 2017)

A total of 81 patients with LIV-1-expressing metastatic breast cancer were treated with ladiratuzumab vedotin monotherapy given every three weeks. Patients enrolled in the study had received a median of four prior systemic metastatic therapies. Of these patients, 63 were diagnosed with TNBC and 18 had hormone receptor-positive / human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. At the completion of dose escalation at doses ranging from 0.5 to 2.8 milligrams per kilogram (mg/kg), TNBC expansion cohorts were opened at 2.0 and 2.5 mg/kg to further evaluate safety and antitumor activity of ladiratuzumab vedotin in metastatic TNBC patients. Based on efficacy and safety, the recommended dose is 2.5 mg/kg with a maximum dose of 200 mg per cycle.

Key findings in this heavily pre-treated patient population were presented by Dr. Jennifer Specht, Seattle Cancer Care Alliance and include:

Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate (ORR) was 25 percent, representing all partial responses (PR). The clinical benefit rate (CBR) was 28 percent. CBR is defined as patients achieving complete response (CR) or PR of any duration, plus patients achieving stable disease (SD) lasting at least 24 weeks. Of the 17 efficacy-evaluable patients treated at the recommended dose, 29 percent achieved an objective response (confirmed and unconfirmed), and the CBR was 29 percent.
The median progression-free survival (PFS) and median duration of response (DOR) for patients treated across all dose levels were 11 weeks and 13.3 weeks, respectively. In 19 patients treated at the recommended dose, the median PFS was 12.1 weeks, and the median DOR was 17.4 weeks.
At the recommended dose, ladiratuzumab vedotin was generally well-tolerated and most adverse events were Grade 1/2.
Of the 81 patients treated in the study, peripheral neuropathy events occurred in 16 patients (19.8 percent) and were generally low grade (Grades 1/2) and manageable. Seven patients discontinued treatment due to adverse events.
Grade 3/4 adverse events included neutropenia and anemia. The Grade 3/4 incidence of neutropenia at the 2.5 mg/kg dose was 38.7 percent. As previously reported, two patients experienced febrile neutropenia, and there was one treatment-related death due to presumed sepsis among patients who received doses greater than 200 mg. No other treatment-related deaths occurred in the study.
Enrollment continues for patients with metastatic TNBC at the recommended dose of 2.5 mg/kg, with a maximum dose of 200 mg per cycle.
Additional details about this spotlight poster presentation (Poster PD3-14) are available here. More information about the ladiratuzumab vedotin phase 1 clinical trial in TNBC, including enrollment centers, is available by visiting www.clinicaltrials.gov.

About Triple Negative Breast Cancer

Breast cancer is the most common cancer among women in the United States, excluding some forms of skin cancer. Of the more than 250,000 new cases expected in the United States this year, about 15 to 20 percent will be TNBC, which has a particularly poor prognosis. Breast cancers are commonly categorized by the expression (or lack thereof) of three proteins, which include the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). TNBC lacks expression of these three breast cancer-associated proteins that serve as key therapeutic targets. About one-third of breast cancer patients will eventually develop recurrent or metastatic disease, and current therapies for metastatic TNBC only delay progression. New treatment approaches are needed to improve outcomes for women with TNBC, where there are currently no available targeted therapies.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics’ proprietary ADC technology. Most metastatic breast cancers express LIV-1, which also has been detected in a number of other cancers, including melanoma, prostate, ovarian, uterine, and cervical cancers. Ladiratuzumab vedotin consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker, using the same technology as ADCETRIS (brentuximab vedotin). This novel ADC agent is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response. Seattle Genetics currently has four clinical studies underway or planned for ladiratuzumab vedotin in breast cancer with a focus on TNBC.

On December 7, 2017 Sanofi reported that it has launched two new late-stage clinical studies to determine if an investigational biologic called isatuximab, when used in combination with other commonly used cancer treatments, might be an effective treatment option for certain people with multiple myeloma, a rare blood cancer related to lymphoma and leukemia. Isatuximab is an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with relapsed and previously untreated multiple myeloma (Press release, Sanofi Genzyme, DEC 7, 2017, View Source [SID1234522429]).

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"The start of two new Phase 3 trials will provide further clinical data as we continue to advance the development of isatuximab," said Joanne Lager, M.D. Head of Oncology Development, Sanofi. "Our multi-study program across major multiple myeloma segments aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens. We are committed to developing a potential new treatment option for a continuum of patients with multiple myeloma, a population with high unmet need."

Late-stage studies include approximately 750 patients with multiple myeloma

IKEMA study is a 325-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with carfilzomib and dexamethasone against carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma that have previously been treated with one-to-three lines of therapy.
IMROZ study is a 425-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with bortezomib, lenalidomide and dexamethasone against bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients not eligible for transplant.
Both studies will evaluate progression-free survival as the primary endpoint. Key secondary endpoints include overall survival, overall response rate, depth of response, safety and quality of life.

Isatuximab granted orphan designation
Isatuximab has been granted orphan designation in the U.S. and European Union. In December 2016, Sanofi started an additional Phase 3 study (ICARIA), comparing isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. The development program for isatuximab will now total three Phase 3 studies.

Other isatuximab data being presented at upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting
Findings from additional ongoing studies of isatuximab will be presented during poster sessions at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, December 8-12, in Atlanta, GA, including the following abstracts:

Saturday, December 9, 5:30 p.m.-7:30 p.m.:

Updated Results from a Phase Ib Study of Isatuximab Plus Pomalidomide (Pom) and Dexamethasone (dex) in Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract: 1887
Presenter: Dr. Paul Richardson
"In Vivo Vaccination" Effect in Clinical Responders to Anti-Myeloma Monoclonal Antibody Isatuximab
Abstract: 1830
Presenter: Dr. Tim Luetkens
Sunday, December 10, 6:00 p.m. -8:00 p.m.:

A Phase Ib Study of Isatuximab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (VCDI) in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation
Abstract: 3160
Presenter: Dr. Enrique M. Ocio
Pre-Clinical Efficacy of the Anti-CD38 Monoclonal Antibody (mAb) Isatuximab in Acute Myeloid Leukemia (AML)
Abstract: 2655
Presenter: Tomas Jelinek

On December 7, 2017 Neon Therapeutics, a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported that it has entered a clinical trial collaboration with Merck (known as MSD outside the United States and Canada) to evaluate Neon Therapeutics’ proprietary personal neoantigen vaccine, NEO-PV-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), along with chemotherapy (Press release, Neon Therapeutics, DEC 7, 2017, View Source [SID1234522428]).

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NEO-PV-01 is Neon Therapeutics’ most advanced product candidate, and is a personal neoantigen vaccine based on DNA mutations from each patients’ tumor. Neon Therapeutics and Merck will collaborate on a Phase 1b clinical trial that will examine the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA, pemetrexed and carboplatin in patients with untreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Additionally, the trial will assess neoantigen-specific immune responses in peripheral blood and tumor tissue, and other markers of immune response.

"We believe there is a strong mechanistic rationale to explore the combination of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "Together with a growing set of clinical collaborators, we are working to amass a diverse set of clinical data to understand the potential of NEO-PV-01 to improve durability and response rates in combination with multiple immuno-oncology targets."

The collaboration agreement is between Neon Therapeutics, Inc. and Merck, through a subsidiary. Additional details were not disclosed.