On April 27, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence (Press release, Hoffmann-La Roche, APR 27, 2018, View Source [SID1234525793]). A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future.

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 goal of treating early breast cancer is to provide the best chance for a cure. This is why we believe that building on the existing therapies is so vital," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s announcement brings hope that patients in Europe with HER2-positive early breast cancer, who are at a high risk of recurrence, will soon have a new treatment option to reduce the chance of their disease returning and potentially progressing to an incurable stage."

The CHMP recommendation is based on results from a large phase III study (APHINITY) involving over 4,800 people with HER2-positive eBC.1 At the time of the primary analysis, with a median follow-up of 45.4 months, the Perjeta-based regimen significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population (HR=0.81, 95% CI 0.66-1.00, p=0.045).1

The Perjeta-based regimen showed the greatest benefit in patients who are at high risk of recurrence:1

For patients with lymph node-positive disease, the risk of recurrence or death was reduced by 23% with the Perjeta-based regimen (HR=0.77; 95% CI 0.62-0.96, p=0.019).
Among patients with hormone receptor-negative disease, the Perjeta-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.085).
The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.1

Every year, almost 100,000 people in Europe are diagnosed with HER2-positive breast cancer, an aggressive type of the disease if left untreated.2,3,4 The majority of breast cancer cases are diagnosed at an early stage where the goal of treatment is to cure.5,6 In the eBC setting, treatment may be given before surgery to shrink tumours and after surgery to help prevent the cancer from returning.7,8 Despite advances in the treatment of HER2-positive eBC, one in four people treated with Herceptin and chemotherapy will eventually see their cancer return in the long-term.9 There is currently no cure for breast cancer that recurs and reaches an advanced stage and treatment for advanced disease is given to prolong life for as long as possible.10

For people diagnosed with HER2-positive eBC, the Perjeta-based regimen has already been approved for use before surgery in the EU, the US and many other countries.11,12 In December 2017, the US Food and Drug Administration (FDA) also approved the Perjeta-based regimen as a post-surgery treatment of HER2-positive eBC at high risk of recurrence.11 Patients in the US with HER2-positive eBC, eligible for the Perjeta-based regimen, should therefore receive Perjeta and Herceptin for 18 cycles, irrespective of the time of surgery, to complete one year of treatment.11

The combination has also been previously approved for the treatment of people with advanced HER2-positive breast cancer, where it has been shown to significantly extend survival compared to Herceptin and chemotherapy alone.11, 12 ,13

Perjeta works in combination with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor, thus preventing tumour cell growth and survival.14

For more information about HER2-positive breast cancer and the goals of treatment, visit our Breast Cancer Hub on roche.com.

About APHINITY 1
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is invasive disease-free survival (iDFS), which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.

About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.15,16 Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.14,17

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.2 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla (trastuzumab emtansine).

Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

On April 27, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine reported that Mark C. Capone, president and CEO, is scheduled to present at two upcoming investor conferences (Press release, Myriad Genetics, APR 27, 2018, View Source [SID1234525794]). On May 8, 2018, Mr. Capone will present at the 43rd annual Deutsche Bank Healthcare Conference in Boston at 12:50 p.m. ET. On May 16, 2018, Mr. Capone will present at the Bank of America Healthcare Conference in Las Vegas, Nevada at 6:40 p.m. ET.

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 presentations will be available to interested parties through a live audio webcast accessible through a link in the investor information section of Myriad’s website at www.myriad.com.

On April 27, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from a large prospective process-intervention study that evaluated genetic testing practices in the obstetrics-gynecology setting will be presented at the 2018 ACOG annual meeting in Austin, Texas (Press release, Myriad Genetics, APR 27, 2018, View Source [SID1234525795]). The key findings are that 23.8 percent of patients qualified for genetic testing based on National Comprehensive Cancer Network (NCCN) guidelines and 5.5 percent of patients who underwent testing were found to carry a pathogenic mutation.

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!

"Myriad is committed to helping obstetricians and gynecologists incorporate genetic testing into their practices and help expand patients’ access to personalized medicine," said Royce (Terry) Adkins, M.D., FACOG, board certified ob-gyn physician and vice president of Medical Affairs, Myriad Genetic Laboratories. "Importantly, this study found that process-intervention strategies and the myRisk Hereditary Cancer test can help doctors find women at increased risk of hereditary breast and ovarian cancers so that steps can be taken to lower their risk."

The study data are summarized below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about ACOG annual meeting news and updates by using the hashtag #ACOG18.

Title: Hereditary Cancer Genetic Testing in Community-Based Obstetrics and Gynecology Settings.
Presenters: Mark S. DeFrancesco, M.D., FACOG, Women’s Health Connecticut and
Richard N. Waldman, M.D., FACOG, Associates for Women’s Medicine.
Date: Saturday, April 28, 2018, 3:30 to 4:30 p.m. CST.
Poster Location: Session K, #3K.

The study evaluated the impact of incorporating routine hereditary cancer risk assessment, counseling and follow-up genetic testing in the community obstetrics-gynecology practice setting. The trial included two large obstetrics-gynecology practice groups in two states with five practice sites. The process intervention included baseline process assessment, refinement of clinic-specific patient screening workflows and tools and training in hereditary cancer risk screening and follow-up. Outcomes related to hereditary cancer screening and testing were measured during an eight-week post-intervention period. Patients and providers also were surveyed about satisfaction with the process.

The results show that 3,811 women were screened for hereditary cancer risk. Among those screened, 23.8 percent met NCCN guidelines for genetic testing. Of those screened, 39 percent agreed to undergo genetic testing with the myRisk Hereditary Cancer test. Importantly, the myRisk Hereditary Cancer test found pathogenic mutations in more than five percent of women tested. All healthcare providers in this study said they would continue to use the established hereditary cancer risk assessment process. Additionally, 98.8 percent of patients referred for genetic testing were able to understand the information provided and 97.6 percent were satisfied with the overall process.

"This study demonstrates that it is feasible and beneficial to incorporate hereditary cancer screening, education and testing into community obstetrics-gynecology practices," said Mark DeFrancesco, M.D., study investigator and managing partner at Westwood Women’s Health in Waterbury, Connecticut, a division of Women’s Health Connecticut. "Patients and providers were satisfied, and integrating multigene panel testing in this setting identified patients with significant cancer risks who would not otherwise have been identified."

The findings from this study also support an ACOG position statement called Access to Genetic Testing, which was released in January 2018.

"Importantly, this study supports the ACOG position that obstetrician-gynecologists are qualified to counsel and order genetic tests by incorporating hereditary cancer screening into routine practice," said Richard N. Waldman, M.D., study investigator and president of Associates for Women’s Medicine. "Understanding a woman’s hereditary cancer risk can dramatically impact medical management to prevent or delay cancer occurrence and to inform cancer care."

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 28 clinically-significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

On April 27, 2018 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its first quarter 2018 financial results after the market close on Monday, April 30, 2018 (Press release, Medpace, APR 27, 2018, View Source [SID1234525797]). The Company will host a conference call the following morning, Tuesday, May 1, 2018, at 9:00 a.m. ET to discuss these results.

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!

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 5992038.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, May 1, 2018 until 12:00 p.m. ET on Tuesday, May 15, 2018. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 5992038.

On April 27, 2018 Haihe Biopharma Co., Ltd. and 3D Medicines (Beijing) Co., Ltd. reported that the two sides have reached a strategic collaboration agreement on HaiHe Biopharma’s FGFR inhibitor (coded HH185) project (Press release, 3D Medicines, APR 27, 2018, View Source [SID1234594049]). 3DMed may carry out the R&D, manufacture and commercialization of HH185 in mainland China, Hong Kong, Macao and Taiwan for the treatment of cancer and pulmonary fibrosis.

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!

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented,
"As a potential target in the field of anti-tumor, FGFR is undergoing rapid development in the research of its mechanisms and clinical application and more and more verifications has been made. Therefore, the R&D prospect is so promising. As a highly selective FGFR inhibitor, HH185 overcomes the adverse effect of hepatotoxicity found in the first-generation FGFR inhibitor and has the apparent anti-tumor activity. We look forward to working together with 3DMed on the further development and commercialization of HH185, so as to accelerate the launch of the domestically-manufactured new drugs and to meet the patients’ needs in China."

Dr. Gong Zhaolong, CEO of 3D Med, commented,
"We are very happy to reach the strategic collaboration agreement with HaiHe Biopharma on HH185.HH185 has a good prospect of combination with 3DMed’s PD-L1 antibody in the field of immuno-oncology therapy. Through the collaboration with HaiHe Biopharma and by virtue of 3DMed’s platform and experience in the field of precision cancer care, we hope to be able to develop new drugs that are urgently needed in clinical practice for the benefit of even more patients who suffer from cancer and pulmonary fibrosis."

About HH185
HH185 is a small molecule inhibitor of fibroblast growth factor receptor 1,2,3 (FGFR 1,2,3), which obtained the approval for clinical trial by CNDA in January 2018. Preclinical studies have shown that HH185 has such advantages as strong anti-tumor activity, excellent PD-PK characteristics, low toxicity and high bioavailability and so on. Moreover, it is targeting CSF1-R and is therefore suitable for combination therapy with PD-1/PD-L1 antibodies in the field ofimmune-oncology.