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Spectrum Pharmaceuticals Highlights Three Abstracts of Clinical Data at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, June 2-6, 2017

On June 2, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported presentations of clinical data for FOLOTYN (pralatrexate injection) and MARQIBO (vinCRIStine sulfate LIPOSOME injection) to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, Illinois, from June 2- 6, 2017 (Press release, Spectrum Pharmaceuticals, JUN 2, 2017, View Source [SID1234519351]).

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For more information about the ASCO (Free ASCO Whitepaper) Annual Meeting and for a complete list of abstracts, please refer to the conference website at View Source

FOLOTYN() (pralatrexate injection) related abstract:

Monday June 5, 2017, 8:00 AM-11:30 AM CDT

Abstract # Type Title First Author Location
7521
Poster Innovative approach to determine overall survival (OS) benefit for orphan diseases using case match control analyses (CMCA): The PROPEL experience of pralatrexate in patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). O’Connor Hall A

MARQIBO (vinCRIStine sulfate LIPOSOME injection) related abstracts:

Saturday June 3, 2017, 3:00 PM-6:00 PM CDT

Abstract # Type Title First Author Location
7506 Oral Radiotherapy to bulky disease PET-negative after immunochemotherapy in elderly DLBCL patients: Results of a planned interim analysis of the first 187 patients with bulky disease treated in the OPTIMAL > 60 study of the DSHNHL. Pfreundschuh S100bc

Monday June 5, 2017, 8:00 AM-11:30 AM CDT

Abstract # Type Title First Author Location
7539 Poster Anti-infective prophylaxis with aciclovir and cotrimoxazole to reduce the rate of infections and therapy-associated deaths in elderly patients with DLBCL undergoing R-CHOP immunochemotherapy. Murawski Hall A

Progenics Pharmaceuticals Announces the Presentation of Data From Two Automated Bone Scan Index Studies at the 2017 ASCO Annual Meeting

On June 2, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, reported the presentation of two studies highlighting the use of an automated bone scan index (aBSI) in men with bone-metastatic castration-resistant prostate cancer (CRPC) at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6 in Chicago, Illinois (Press release, Progenics Pharmaceuticals, JUN 2, 2017, View Source [SID1234519350]).

The vast majority of men with CRPC have bone metastases and bone scans are the standard imaging modality in these patients. Bone scans indirectly assess tumor activity by measuring bone mineral turnover. The bone scan index quantifies the prostate cancer disease burden shown on a bone scan. Employing artificial intelligence, the aBSI automatically calculates the bone scan index. aBSI permits a faster quantitative assessment of tumor burden compared to manual BSI and is highly reproducible

The first study, entitled, "Phase 3 prognostic analysis of the automated bone scan index (aBSI) in men with bone-metastatic castration-resistant prostate cancer (CRPC)," will be featured during an oral presentation on June 3rd. This study is the first evaluation of aBSI in a phase 3 study as a prognostic biomarker for survival in patients with bone-metastatic CRPC. The study demonstrated that in these patients, aBSI at baseline was prognostic for overall and disease specific survival (p <0.0001), progression free survival (p =0.0024), radiographic progression-free survival (rPFS) (p =0.0061), and symptomatic skeletal related events (SSEs) (p =0.0068).

"This large scale study highlights the ability of the aBSI to provide clinically meaningful prognostic information to patients with bone-metastatic CRPC, using a quantitative software method to assess the burden of bone metastases," said Andrew Armstrong, MD ScM FACP, Associate Professor of Medicine and Surgery, Associate Director for Clinical Research in Genitourinary Oncology Duke Cancer Institute, Duke University, Durham, NC. "This is the largest study to date of this bone scan index and we demonstrate clinically important outcomes associated with increasing BSI including mortality and symptomatic progression, independent of other known factors."

The second study will be presented at ASCO (Free ASCO Whitepaper) on June 5th as a poster titled "Translating Prostate Cancer Working Group (PCWG) Criteria into a Quantitative Progression Biomarker in Metastatic Castration Resistant Prostate Cancer (mCRPC)". This study demonstrates the utility of automated bone scan indexing to quantitatively assess total tumor burden during the course of disease progression as called for by PCWG2 criteria.

"Historically, assessing treatment effects in prostate cancer has been complicated by the dominance of bone metastases relative to soft tissue disease, making it difficult to accurately assess changes in disease burden over time in patients with mCRPC," said Michael J. Morris, MD of Memorial Sloan Kettering Cancer Center. "There is a significant need for a fully quantitative biomarker to demonstrate treatment response in these patients, and the current data are encouraging that the aBSI reflects clinically relevant changes in bone, and may fulfill this unmet need."

The schedule for the presentations at ASCO (Free ASCO Whitepaper) is as follows:

Date & Time: Saturday, June 3, 2017, 1:15 PM-4:15 PM

Session Title: Genitourinary (Prostate) Cancer

Session Type: Oral Abstract Presentation

Title: Phase 3 prognostic analysis of the automated bone scan index (aBSI) in men with bone-metastatic castration-resistant prostate cancer (CRPC)

Location: Hall B1

Abstract No.: 5006

Date & Time: Monday, June 5, 2017, 1:15 PM-4:15 PM

Session Title: Genitourinary (Prostate) Cancer

Session Type: Poster Session

Title: Translating Prostate Cancer Working Group (PCWG) criteria into a quantitative progression biomarker in metastatic Castration Resistant Prostate Cancer (mCRPC)

Location: Hall A, Poster Board # 142

Abstract No.: 5068

Myriad Genetics Announces Results from a Large 2,000 Patient Clinical Utility Study of Its myRisk® Hereditary Cancer Test at the 53rd Annual Meeting of ASCO

On June 2, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported results from Study 005, a large 2,000 patient prospective study of the Myriad myRisk Hereditary Cancer test, which will be featured in three poster presentations at the 53rd annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Myriad Genetics, JUN 2, 2017, View Source [SID1234519349]).

The data will be presented by research collaborators from University of Southern California (USC) Norris Comprehensive Cancer Center and Stanford University Cancer Institute. The key findings are that more than 50 percent of the mutations identified were in patients who would not meet current testing guidelines and 34 percent of mutations were identified in unexpected genes, confirming the clinical utility of multi-gene panel testing to improve hereditary cancer-risk assessment.

"We are very excited to present new data on our myRisk Hereditary Cancer test which shows our ongoing commitment to collaborate with leading academic centers and advance the field of hereditary cancer testing," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Importantly this study demonstrates that more than half of mutations would be missed with current testing guidelines and 34 percent of mutations identified were unexpected and not predicted by personal and/or family history. This study will provide vital data to facilitate review of medical guidelines in light of advances made in next generation sequencing."

The data are highlighted below and abstracts are available at: abstracts.asco.org.

myRisk Hereditary Cancer Poster Presentations
Title: Performance of Mutation Risk Prediction Models in a Racially Diverse Multi-Gene Panel Testing Cohort.
Presenter: Gregory Idos, M.D., USC Norris Comprehensive Cancer Center.
Date: Monday, June 5, 2017, 1:15 — 4:45 p.m.
Location: Poster 181; Abstract 1523

National Comprehensive Cancer Network (NCCN) guidelines recommend germline genetic testing for patients with a mutation carrier probability (CP) score of five percent or higher. An analysis of data from Study 005 evaluated the percentage of pathogenic mutations in a population of racially diverse patients with a CP score less than five percent. In total 2,000 patients were tested using the myRisk Hereditary Cancer test and 242 were found to have pathogenic mutations. The results showed that more than 50 percent of patients with BRCA1/2 or mismatch repair (MMR) mutations had a CP score less than five percent. Four percent of patients with BRCA1/2 mutations did not meet NCCN guidelines for hereditary breast and ovarian cancer syndrome, and 13 percent of patients with MMR mutations did not meet NCCN criteria for Lynch syndrome testing. Importantly, these findings support lowering the guideline-recommended CP threshold for genetic testing to help ensure that more patients can access genetic testing.

Title: Yield of multiplex panel testing exceeds expert opinion and validated prediction models.
Presenter: Gregory Idos, M.D., USC Norris Comprehensive Cancer Center.
Date: Monday, June 5, 2017, 1:15 — 4:45 p.m.
Location: Poster 183; Abstract 1525.

Data from Study 005 were evaluated to determine the diagnostic yield and clinical utility of panel testing using the myRisk Hereditary Cancer 28-gene test in 2,000 patients undergoing hereditary cancer-risk assessment. Approximately 81 percent of patients were women and 40 percent were Hispanic. Differential diagnoses were generated after standard clinical genetics assessment and before genetic testing. Differences between the differential diagnoses and genetic testing results were evaluated to determine the added diagnostic yield of multi-gene panel testing. The results show that 12.1 percent of patients tested positive for a pathogenic mutation. The most common mutations were in BRCA1 (17 percent) and BRCA2 (15 percent), APC (8 percent), CHEK2 (7 percent) and ATM (7 percent). Importantly, however, 34 percent of the mutations were not clinically suspected before genetic testing, which demonstrates the significant added value of the myRisk Hereditary Cancer test in hereditary cancer-risk assessment.

Title: Yield of multiplex panel testing exceeds expert opinion and validated prediction models.
Presenter: Allison Kurian, M.D., Stanford University Cancer Institute.
Date: Monday, June 5, 2017, 1:15 — 4:45 p.m.
Location: Poster 234; Abstract 1576.

Study 005 also evaluated the safety of gene panel testing among patients who were undergoing cancer-risk assessment with the myRisk Hereditary Cancer test. The analysis of 2,000 patients found that 12.1 percent of patients had pathogenic mutations. Overall, self-reported preventative surgery rates were low (mastectomy 9.2 percent, hysterectomy 1.6 percent, and oophorectomy 1.8 percent). There was no difference in preventative surgery rates between patients with a variant of uncertain significance (VUS) and mutation negative patients (p=0.21). Importantly, most patients never/rarely had thoughts of cancer affecting their daily activities, did not regret genetic testing and wanted to know all the results. Patients with a pathogenic mutation reported higher distress and uncertainty scores than VUS or negative patients, whose distress (p=0.06) and uncertainty (p=0.04) scores were similar. Relatives of mutation positive patients completed genetic testing more often than VUS or negative patients. This study demonstrated that multi-gene panel testing did not result in inappropriate medical management or increased distress/uncertainty among VUS and negative patients.

"The use of multi-gene panels for the clinical assessment of hereditary cancer risk is rapidly increasing in the era of personalized medicine and it’s important that we understand the benefits and risks of genetic testing on patients," said Lancaster. "Study 005 showed that multi-gene panel testing effectively improved hereditary cancer risk assessment and the results did not lead to unwarranted treatment or adverse effects."

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including:

Unsurpassed lab accuracy:
85,000 base pairs with ~100 percent accuracy.
856 steps using 23 major technology platforms.
100 proprietary software applications.

Industry leading variant classification:
More than 20 years of investment in research.
>2.5 million patients tested; 50,000 variants identified.
Five proprietary methods with 99.5 percent validity.

Exceptional customer service:
More than 40,000 ordering physicians annually.
450 field educators.
Extensive reimbursement support.
Lifetime commitment to patients.

Innate Pharma strengthens its proprietary pipeline with the acquisition of anti-C5aR, a first-in-class clinical-stage antibody,from novo Nordisk A/S

On June 2, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it enters into an agreement with Novo Nordisk A/S granting Innate Pharma full worldwide exclusive rights to develop and commercialize a first-in-class clinical-stage anti-C5aR antibody (IPH5401) representing a novel therapeutic approach in immuno-oncology (Press release, Innate Pharma, JUN 2, 2017, View Source [SID1234519348]).

IPH5401 is a strategic fit to Innate Pharma’s current immuno-oncology pipeline. It adds a clinical-stage proprietary product that reinforces Innate Pharma’s position in the field of antibodies targeting the tumor microenvironment beyond the Company’s activities in the adenosine pathway. Innate Pharma plans to start trials with IPH5401 in oncology in 2018.

Through C5aR triggering, C5a induces accumulation and activation of myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. These cells are associated with a poor prognosis across numerous tumor types. They secrete pro-tumor and pro-angiogenic factors and have emerged as a major immunosuppressive mechanism, associated with resistance to checkpoint blockers. By targeting and blocking this pathway, anti-C5aR has the potential to enhance anti-tumor immunity across a range of solid and hematologic tumors.

Novo Nordisk A/S has conducted two Phase I trials with anti-C5aR in patients with rheumatoid arthritis, where a good safety profile was demonstrated.

The terms of the transaction provide for a total upfront payment of €40m, of which €37.2m will be paid in new Innate Pharma shares and €2.8m in cash. Novo Nordisk A/S will be eligible for €370m in development, regulatory and sales milestone payments. Novo Nordisk A/S will also be eligible for double digit royalties on net sales.

After the issuance of the new Innate Pharma shares, the stake of Novo Nordisk A/S in Innate Pharma will increase from 10.3% currently to between 14.6% to 15.8% (See "About the transaction section").

The closing is expected to take place on July 12, 2017 at the latest.

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "With the acquisition of the first-in-class anti-C5aR antibody, we are broadening our proprietary clinical pipeline. We believe anti-C5aR has a high potential for cancer patients in multiple indications and look forward to beginning clinical development of this promising asset in 2018. Innate Pharma has a strong track record of value creation from in-licensed assets with lirilumab and monalizumab. This acquisition strengthens our asset base further and supports Innate Pharma’s transition towards becoming a fully-integrated biopharmaceutical company."

Mads Krogsgaard Thomsen, Chief Science Officer of Novo Nordisk A/S, added: "In light of Innate’s success within the immuno-oncology field, we believe that Innate is the ideal partner for the anti-C5aR program and we are looking forward to seeing the program advance further in development."

Novartis presents updated data that reinforce the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a first-line option for HR+/HER2- advanced or metastatic breast cancer

On June 2, 2017 – Novartis reported updated findings from the Phase III MONALEESA-2 study that reinforce the efficacy and safety of Kisqali (ribociclib) plus letrozole in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (Press release, Novartis, JUN 2, 2017, View Source [SID1234519346]). After an additional 11 months of follow-up, a median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) for Kisqali plus letrozole and 16.0 months (95% CI: 13.4-18.2) for letrozole alone was observed (HR=0.568 (95% CI: 0.457-0.704; p<0.0001))[1]. These data will be presented on Sunday, June 4, 2017 at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Abstract #1038).

These updated results further support that Kisqali plus letrozole improves PFS as a first-line treatment across all patient subgroups[1]. After two years of treatment, the progression-free survival rate was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone[1]. In a cohort of 213 US patients treated as part of MONALEESA-2, the median PFS was 27.6 months with Kisqali plus letrozole and 15.0 months with letrozole alone (HR=0.527 (95% CI: 0.351-0.793))[1].

Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo[1]. In women with measurable disease at baseline, 55% saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% with letrozole plus placebo[1]. Follow-up to measure overall survival is ongoing as data remain immature[1].

"This new look at the MONALEESA-2 data, after an additional year of follow-up, demonstrates the continued efficacy of ribociclib plus letrozole," said Gabriel N. Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and MONALEESA-2 Principal Investigator. "With more than two years of follow-up, the PFS data confirm the inclusion of ribociclib plus an aromatase inhibitor as a strong option among first-line treatments for HR-positive, HER2-negative advanced breast cancer."

A separate analysis of patient-reported, health-related quality of life (HRQoL) outcomes from the MONALEESA-2 trial presented at ASCO (Free ASCO Whitepaper) (Abstract #1020) showed no significant difference in quality of life for women taking Kisqali plus letrozole compared to those taking letrozole alone[2]. This suggests that adverse events did not significantly impact HRQoL[2].

Updated safety data from the MONALEESA-2 trial show the safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities is similar to that observed at the first interim analysis[1]. At the time of this updated analysis, the most common (>=10%) grade 3/4 laboratory abnormalities were as follows for Kisqali plus letrozole compared to letrozole alone: decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%)[1].

"Updated MONALEESA-2 results validate the sustained efficacy and established safety profile of Kisqali plus letrozole in patients with HR+/HER2- metastatic breast cancer and confirm the data that supported its recent FDA approval," said Vas Narasimhan, MD, Head, Global Drug Development and Chief Medical Officer, Novartis. "We are excited about the potential of Kisqali, and are continuing to evaluate its activity in several Phase III trials with multiple hormonal therapy combinations across a broad range of patient populations, including in the adjuvant setting. We look forward to sharing new results with the scientific community in the coming months and years."

The MONALEESA clinical trial program includes two additional Phase III trials in advanced breast cancer, MONALEESA-3 and MONALEESA-7, which are evaluating the efficacy and safety of Kisqali in combination with other endocrine partners. Novartis also is enrolling patients in a study to further evaluate Kisqali in men and pre- or postmenopausal women (CompLEEment-1) and initiating Phase III trials evaluating Kisqali in the adjuvant therapy setting (EarLEE-1 and EarLEE-2).

Kisqali was approved by the US Food and Drug Administration (FDA) on March 13, 2017, as a first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor.

Full US prescribing information for Kisqali can be found at View Source

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About the Kisqali Clinical Trial Program
MONALEESA-3 is evaluating Kisqali in combination with fulvestrant compared to fulvestrant alone in postmenopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy. MONALEESA-7 is investigating Kisqali in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in premenopausal women with HR+/HER2- advanced breast cancer who have not previously received endocrine therapy. These trials are fully enrolled.

Novartis will initiate two multicenter, randomized, double-blind Phase III clinical trials, EarLEE-1 and EarLEE-2, to evaluate the safety and efficacy of Kisqali with endocrine therapy as adjuvant therapy in pre- and postmenopausal women who have not previously received treatment with CDK4/6. EarLEE-1 will assess Kisqali with adjuvant endocrine therapy compared to adjuvant endocrine therapy alone in women with HR+/HER2- high-risk early breast cancer. EarLEE-2 will investigate Kisqali with adjuvant endocrine therapy compared to adjuvant endocrine therapy alone in women with HR+/HER2- intermediate-risk early breast cancer.

The CompLEEment study is evaluating the safety and efficacy of Kisqali plus letrozole in men and pre- or postmenopausal women with HR+/HER2- advanced breast cancer with no prior hormonal therapy for advanced disease. This open-label, multicenter, Phase IIIb CompLEEment-1 trial is currently enrolling participants.

More information about these studies can be found at ClinicalTrials.gov.About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.

Kisqali (ribociclib) Important US Safety Information
Kisqali (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor as the first hormonal-based therapy to treat women who have gone through menopause with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if Kisqali is safe and effective in children. Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby. Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Kisqali. The most common side effects (incidence >=20%) of Kisqali when used with letrozole include white blood cell count decreases, nausea, tiredness, diarrhea, hair thinning or hair loss, vomiting, constipation, headache, and back pain. The most common grade 3/4 side effects in the Kisqali + letrozole arm (incidence >2%) were low neutrophils, low leukocytes, abnormal liver function tests, low lymphocytes, and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.