10-Q – Quarterly report [Sections 13 or 15(d)]

Myovant Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Myovant Sciences, 2017, DEC 9, 2016, View Source [SID1234522023]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Novartis LEE011 (ribociclib) plus letrozole analyses show superior PFS across broad spectrum of patients in first-line HR+/HER2- advanced breast cancer versus letrozole

On December 9, 2016 Novartis reported additional analyses from the Phase III MONALEESA-2 study that show LEE011 (ribociclib) plus letrozole significantly prolonged progression-free survival (PFS) across pre-planned patient subgroups with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, including post-menopausal women diagnosed de novo, those with visceral liver and lung metastases, and those with bone-only disease[1],[2] (Press release, Novartis, DEC 9, 2016, View Source [SID1234517015]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

These findings demonstrate the strength of LEE011 plus letrozole in the first-line setting, showing that treatment benefit was evident across all patient subgroups regardless of their disease burden or tumor location, including those patients with aggressive disease. Data will be presented today at the San Antonio Breast Cancer Symposium (SABCS) (Abstracts P4-22-05 and P4-22-16).

"Results from the de novo subgroup of women in the MONALEESA-2 trial establish ribociclib in combination with letrozole as a meaningful treatment option in the first-line setting for this patient population," said Joyce O’Shaughnessy, MD, Co-Chair, Breast Cancer Research, Texas Oncology-Baylor Charles A. Sammons Cancer Center. "These de novo patients are often diagnosed initially with advanced breast cancer that has already metastasized, so it is critical to start them with treatments that extend time until disease progression."

"Breast cancer that has metastasized to areas such as the liver or lungs can often be more challenging to effectively treat with current standards of care," said Howard A. Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. "We have been encouraged by the MONALEESA-2 results because treatment benefit was observed regardless of the number of metastatic sites and was maintained across all subgroups taking ribociclib plus letrozole. Our observations indicate that this novel therapy may be a promising treatment option for many patients living with advanced forms of breast cancer."

First-line ribociclib + letrozole in patients with de novo HR+, HER2- advanced breast cancer: A subgroup analysis of the MONALEESA-2 trial (Abstract P4-22-05)
A predefined subgroup analysis of the MONALEESA-2 trial evaluated the safety and efficacy of LEE011 plus letrozole versus letrozole alone in 227 patients with de novo advanced breast cancer, defined as disease found to be metastatic at the time of first diagnosis[1]. Because de novo disease has not been previously treated with systemic treatment for early-stage breast cancer, tumors may exhibit a different disease biology, which could result in varied responses compared to patients who experienced recurrence[1]. In patients with de novo advanced breast cancer, LEE011 plus letrozole reduced the risk of disease progression or death by 55% over letrozole alone (HR=0.448 [95% CI: 0.267-0.750])[1]. The 12-month PFS rate was 82% in the LEE011 plus letrozole arm compared to 66% with letrozole alone.

Consistent with the overall study population, most adverse events were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and reduction[1]. The most common grade 3/4 adverse events (>=15% of patients with de novo advanced breast cancer; LEE011 plus letrozole vs. letrozole alone) were neutropenia (55.3% vs. 0.9%) and leukopenia (21.1% vs. 0%)[1].

First-line ribociclib + letrozole in patients with HR+, HER2- advanced breast cancer presenting with visceral metastases or bone-only disease: A subgroup analysis of the MONALEESA-2 trial (Abstract P4-22-16)
In separate predefined subgroups, 393 patients with advanced breast cancer with visceral metastases and 147 patients with bone-only disease were evaluated as part of the MONALEESA-2 trial. Those with visceral metastases have metastatic growth at the site of the lung or liver, and typically have a poorer prognosis than patients with non-visceral disease[2]. Results of these analyses show that first-line LEE011 plus letrozole was well tolerated and reduced the risk of disease progression or death by 47% (patients with visceral disease: HR=0.535 [95% CI: 0.385-0.742]) and by 31% (patients with bone-only disease: HR=0.690 [95% CI: 0.381-1.249]) respectively[2]. Treatment benefit with LEE011 in combination with letrozole was observed regardless of the number of metastatic sites and (HR=0.607 (95% CI: 0.437-0.845) among patients with less than 3 metastases; HR=0.456 (95% CI: 0.298-0.700) among patients with 3 or more metastases)[2].

Among patients with visceral metastases the most frequent grade 3/4 adverse events (>=20% of patients; LEE011 plus letrozole vs. letrozole alone) were neutropenia (64.0% vs 1%) and leukopenia (20.8% vs 0.5%)[2]. Among patients with bone-only disease the most frequent grade 3/4 adverse events (>=20% of patients; LEE011 plus letrozole vs. letrozole alone) were neutropenia (53.6% vs 1.3%) and leukopenia (23.2% vs 1.3%)[2].

"These additional results from the MONALEESA-2 study are very promising for women with HR+ advanced breast cancer," said Bruno Strigini, CEO, Novartis Oncology. "We believe LEE011 could significantly benefit a broad range of women as an initial treatment for metastatic breast cancer and look forward to working with global health authorities to bring this new treatment to patients."

The MONALEESA-2 study is ongoing to evaluate secondary endpoints, including overall survival. LEE011 received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) in August 2016 and Priority Review in October 2016.

About LEE011 (ribociclib)
LEE011 (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 in a cell, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring cancer cells do not grow uncontrollably.

LEE011 is not approved for any indication in any market at this time. LEE011 was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About the MONALEESA Clinical Trial Program
Novartis is continuing to assess LEE011 through the robust MONALEESA (Mammary ONcology Assessment of LEE011’s Efficacy and SAfety) clinical trial program, which includes MONALEESA-2, MONALEESA-3, and MONALEESA-7. These trials are evaluating LEE011 in multiple endocrine therapy combinations across a broad range of patients, including men and premenopausal women.

MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer[3].

The trial randomized 668 patients in a 1:1 ratio stratified by the presence of liver and/or lung metastases at 223 clinical trial sites globally[3]. Patients received LEE011 600 mg/daily (three weeks on and one week off), or placebo, in combination with letrozole 2.5 mg/daily.

The primary endpoint of the trial was PFS[3]. Secondary endpoints included: overall survival, overall response rate, clinical benefit rate, health-related quality of life, safety and tolerability[3].

In MONALEESA-2, the most common grade 3/4 (most severe) adverse events were as follows for LEE011 plus letrozole compared to letrozole alone: neutropenia (60% vs 1%), leukopenia (21% vs 1%), elevated alanine aminotransferase (9% vs 1%), lymphopenia (7% vs 1%) and elevated aspartate aminotransferase (6% vs 1%)[1]. The most common all-grade adverse events (>=35% of patients in either arm, regardless of relationship to study treatment) were as follows for LEE011 plus letrozole compared to letrozole alone: neutropenia (74% vs 5%), nausea (52% vs 29%), infections (50% vs 42%), fatigue (37% vs 30%), and diarrhea (35% vs 22%)[1]. Nausea, infections, fatigue, and diarrhea were mostly grade 1 or 2[1].

The MONALEESA-3 trial is a phase III trial evaluating LEE011 in combination with fulvestrant compared to fulvestrant alone in men and post-menopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy.

MONALEESA-7, the largest phase III trial of a CDK4/6 inhibitor in this patient population, is investigating LEE011 in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in pre-menopausal women with HR+/HER2- advanced breast cancer who have not previously received endocrine therapy. Both MONALEESA-3 and MONALEESA-7 are fully enrolled.

About Advanced Breast Cancer
Up to one-third of patients with early-stage breast cancer will subsequently develop metastatic disease[4]. Metastatic breast cancer is the most serious form of the disease and occurs when the cancer has spread to other parts of the body, such as the brain, bones or liver[5]. Advanced breast cancer comprises metastatic breast cancer (stage 4) and locally advanced breast cancer (stage 3)[5]. Survival rates for women living with advanced breast cancer are lower than those for women with earlier stage disease. The 5-year relative survival rate for stage 3 breast cancer is approximately 72%, while metastatic (stage 4) breast cancer has a 5-year relative survival rate of approximately 22%[6].

The EndoPredict® Test Significantly Outperforms the First-Generation Test in Predicting the Risk of Node-Negative and Node-Positive Breast Cancer Recurrence

On December 9, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported results of a large head-to-head study comparing the efficacy of six tests used to predict the recurrence of breast cancer (Press release, Myriad Genetics, DEC 9, 2016, View Source [SID1234517014]). A key finding was that EndoPredict (EPclin), a second-generation test, was superior to Oncotype Dx (RS), a first-generation test, in predicting the long-term recurrence of breast cancer. The results are being featured today in a podium presentation at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In this important study, EndoPredict more accurately predicted the risk of breast cancer recurrence than the first-generation Oncotype Dx test, particularly in years five to 10 following surgery when half of breast cancer recurrences will happen," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Clinicians can consider using EndoPredict to identify patients who can forgo chemotherapy with confidence, knowing they have a low risk of recurrence over 10 years."

Podium Presentation
Title: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC.
Presenter: Ivana Sestak, Ph.D.
Date: Friday, Dec.9, 2016: 4:15 p.m. CT.
Location: S6-05; General Session 6 – Hall 3.

This study was led by scientists at the Institute of Cancer Research in London. The analysis included 818 women with ER+/HER2- breast cancer (591 node-negative; 227 node-positive) from the TransATAC study and compared the power of six predictive signatures, including: clinical treatment score, immunohistochemical markers, Oncotype Dx recurrence score (RS), breast cancer index (BCI), Prosigna and EndoPredict (EPClin). Distant recurrence of breast cancer was the primary endpoint and the median follow-up period was 10 years.

Overall, each of the three second-generation tests evaluated (breast cancer index, Prosigna and EndoPredict) outperformed Oncotype Dx in this cohort in predicting the recurrence of breast cancer in both node-negative and node-positive patients across both zero to 10 and five to 10 years post-surgery. In a head-to-head comparison between EndoPredict and Oncotype Dx in this study:

EndoPredict offered more predictive power than Oncotype Dx across zero to 10 years.
The data show that the likelihood ratio (LRx2, a common measure of predictive power) for EndoPredict was almost double that of Oncotype Dx in node-negative patients (EndoPredict: LRX2= 40.6; Oncotype: LRX2=22.8) and was five times higher in node-positive patients (EndoPredict: LRX2= 35.6; Oncotype: LRX2=6.4).

EndoPredict had superior predictive power over Oncotype Dx between five to 10 years.
The likelihood ratio for EndoPredict was seven times higher than for Oncotype Dx in node-negative patients (EndoPredict: LRX2= 24.0; Oncotype: LRX2=3.4) and 13 times higher in node-positive patients (EndoPredict: LRX2= 14.9; Oncotype: LRX2=1.1). Importantly, the likelihood ratio for Oncotype DX failed to achieve statistical significance in predicting cancer recurrence in years five to 10 for either node-positive or node-negative patients, indicating an inability to predict distant recurrence over the five to 10 year timeframe.

EndoPredict was superior in classifying node-positive patients as low-risk compared to Oncotype Dx.
Node-positive patients classified as low risk by EndoPredict had a substantially lower 10-year recurrence rate (5.6 percent) than patients classified as low risk by Oncotype Dx (26.2 percent) as well as a lower five to 10 year recurrence rate (3.3 percent for EndoPredict vs 17.9 percent for Oncotype Dx).
"Myriad is committed to research that improves care for patients with breast cancer. Patients at high risk of cancer recurrence are candidates for adjuvant chemotherapy after surgery, while those at low risk can be spared chemotherapy and the side effects," said Lancaster. "We believe EndoPredict will help clinicians and patients understand the risk of breast cancer recurrence and identify more patients who can safely forgo chemotherapy. Additionally, EndoPredict does not contain an intermediate risk category and each patient receives a clear test result, allowing oncologists to confidently develop their treatment plan."

The TransATAC study, in part, was previously published in the Journal of the National Cancer Institute (View Source). The current presentation at SABCS expands on that article and provides a comprehensive comparison of prognostic signatures for breast cancer. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS16.

Calithera Biosciences to Host Conference Call and Webcast to Review Data Presented at the San Antonio Breast Cancer Symposium and EORTC-NCI-AACR Symposium

On December 9, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the company will host a live conference call and webcast on Monday, December 12, 2016 at 8:30 a.m. EST (5:30 a.m. PST) to discuss recent CB-839 clinical data presentations at the San Antonio Breast Cancer Symposium, the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, and other recent corporate highlights and business developments (Press release, Calithera Biosciences, DEC 9, 2016, View Source;p=RssLanding&cat=news&id=2228746 [SID1234517011]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 36690670. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

BioInvent terminates current BI-505 Phase II study

On December 9, 2016 BioInvent International (OMXS: BINV) reported that it has decided to terminate its current clinical Phase II study with BI-505 in multiple myeloma (Press release, BioInvent, DEC 9, 2016, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=D31A6036F0928688 [SID1234517021]). The decision follows BioInvent’s review and discussion with the US Food & Drug Administration (FDA), who put BI-505 on full clinical hold in November 2016.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The terminated trial, which was performed in collaboration with Penn Medicine, targeted a specific population of multiple myeloma patients undergoing autologous stem cell transplantation with high-dose melphalan.