On February 15, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported Health Canada’s approval of ZYTIGA (abiraterone acetate) in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who may have received up to three months of prior ADT (Press release, Johnson & Johnson, FEB 15, 2018, View Source [SID1234524007]).

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This latest approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, a multinational, multicenter, randomized, double-blind, placebo-controlled trial (N=1,199) that examined the use of ZYTIGA 1,000 mg once daily in combination with prednisone 5 mg once daily and ADT, compared to placebos plus ADT in patients with newly diagnosed mHSPC.3 The study showed ZYTIGA, in combination with prednisone and ADT reduced the risk of death by 38 per cent compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively; HR=0.62; 95% confidence interval [CI], 0.51 to 0.76; P < 0.001) in patients with mHSPC.4

"Previously men with newly diagnosed metastatic prostate cancer have had limited options for first-line treatments," Dr. Fred Saad, Chief of Urology, Centre Hospitalier de l’Université de Montréal, Université de Montreal and LATITUDE clinical investigator.** "This latest approval for ZYTIGA is an exciting milestone for men, their caregivers and treating clinicians as it provides a new first-line treatment option for high-risk metastatic hormone-sensitive prostate cancer that improves overall survival and quality of life."

About the LATITUDE Study
The LATITUDE study, published in the New England Journal of Medicine,5 enrolled 1,199 newly diagnosed patients with high-risk mHSPC and was conducted at 235 sites in 34 countries, including sites in 10 Canadian cities and with 33 Canadian patients.6,7 A total of 597 patients were randomized within three months of diagnosis to receive ADT plus ZYTIGA and prednisone, while 602 patients were randomized to receive ADT and placebo.8 Patients were high-risk mHSPC as defined as having at least two of the three following factors associated with poor prognosis: Gleason score ≥8, ≥3 bone lesions and/or presence of measurable visceral metastases.9

Overall, the safety profile of ZYTIGA in combination with prednisone and ADT was similar to prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC).10 In the LATITUDE study, patients received a lower dose of prednisone at 5 mg/day with the usual dose of ZYTIGA at 1,000 mg/day plus ADT. The most common all grade adverse reactions (≥10%) observed with ZYTIGA compared to placebo were hypertension (36.7% versus 22.1%), hypokalemia (20.4% versus 3.7%) and hot flushes (15.4% versus 12.5%).

About Prostate Cancer in Canada
Prostate cancer is a disease where prostate cells lose control of growth and division, and are no longer able to function as healthy cells.11,12 It can be slow-growing and go undetected for years.13

Prostate cancer is the most common cancer among Canadian men, with approximately 21,300 men diagnosed each year.14 Roughly 10 to 20 per cent of those living with prostate cancer will present with metastatic disease,15 in which the tumour has spread beyond the prostate to other parts of the body. There is no cure for metastatic prostate cancer.16

Metastatic hormone-sensitive prostate cancer refers to prostate cancer that still responds to testosterone suppression therapy.17 Patients with newly diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.18

About ZYTIGA
ZYTIGA blocks CYP17-mediated androgen production at three sources: in the testes, adrenals and the prostate tumour tissue.19 Androgen production left unchecked fuels the growth of prostate cancer.20

Health Canada first approved ZYTIGA in 2011 to be used in combination with prednisone for the treatment of mCRPC in patients who have received prior chemotherapy containing docetaxel after failure of ADT. In 2013, it was approved for mCRPC in patients who are asymptomatic or mildly symptomatic after failure of ADT.21

On February 15, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that a comparative analysis of commercially available prognostic breast cancer tests in patients with early-stage breast cancer has been published in JAMA Oncology (Press release, Myriad Genetics, FEB 15, 2018, View Source [SID1234524010]). A key finding is that Myriad’s EndoPredict (EPClin) significantly outperformed Oncotype DX Recurrence Score at predicting the risk of disease recurrence in patients with early-stage breast cancer.

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In the article, Sestak et al. compared the prognostic value that four different commercial tests add to the Clinical Treatment Score (nodal status, tumor size, grate, age, endocrine treatment) for predicting distant recurrence (0-10 years) and late-distant recurrence (5-10 years) of breast cancer. The analysis included data from 774 postmenopausal women with ER+/HER2- breast cancer with node-negative disease or up to three positive lymph nodes, which is the most common form of breast cancer.

The results show that in all patients EndoPredict was the best overall test in predicting distant recurrence in years 0-10 (C-index 0.753; LRX2=69.3) and years 5-10 (C-index 0.761; LRX2=41.6). Importantly, EndoPredict identified the largest group of low-risk patients with 10 years distant recurrence below 10 percent in both node-negative and node-positive disease. EndoPredict also was a much better predictor for overall distant recurrence and for late-distant recurrence than Oncotype DX Recurrence Score. The JAMA Oncology publication can be accessed at View Source

"This study demonstrates that EndoPredict, which combines a multigene signature with clinical information, significantly improves the prediction of disease recurrence, specifically in women with node-positive breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "What this means is that EndoPredict can more accurately identify a larger percentage of patients who can safely forgo adjuvant chemotherapy and the associated toxicity."

These findings are consistent with a previous publication in the Journal of the National Cancer Institute, which also found that EndoPredict was superior to Oncotype DX Breast Recurrence Score in predicting the long-term recurrence of ER+, HER2- primary breast cancer.

Additionally, at the 2017 San Antonio Breast Cancer Symposium in December, the Company presented new predictive data that demonstrated women with a high EndoPredict score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low score responded better to neoadjuvant endocrine therapy.

"We are committed to saving and improving the lives of women with breast cancer, and making sure patients are benefitting from the latest advances in personalized medicine," said Lancaster. "Our expanding body of evidence strongly supports the use of EndoPredict to aid in clinical decisions regarding the use of chemotherapy and extended endocrine therapy."

EndoPredict is widely accessible and is covered by more than 90 percent of health insurance plans in the United States. It also is available in several major European markets. For more information, please visit: www.endopredict.com.

Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

Medical Policy Update
One of the largest private insurers in the United States has expanded its coverage policy on EndoPredict. The new policy supports the use of EndoPredict to aid in the controversial decision of whether or not to extend adjuvant hormonal therapy beyond five years of treatment.

"I applaud payers for recognizing the importance of biomarkers to help physicians and patients make important decisions about whether or not to use extended endocrine therapy out to 10 years," said Joyce A. O’Shaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, and Chair of Breast Cancer Research at Texas Oncology. "This is another important step toward making personalized medicine a reality for all patients with breast cancer."

About Breast Cancer

One in eight American women will have breast cancer during her lifetime. Breast cancer is the second leading cause of cancer death among American women. The American Cancer Society estimates in its Cancer Facts & Figures 2018 report that more than 250,000 women will be told they have breast cancer in 2018. Currently, there are nearly 3.5 million American women living with the disease and every 13 minutes another American woman dies from breast cancer. That’s a little more than 40,000 this year.

About EndoPredict

EndoPredict is a second-generation, multigene prognostic test that aids personalized treatment planning for patients with early stage breast cancer. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive disease and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict accurately predicts the likelihood of both early (0-5 years) and late distant recurrence (5-10 years). Thus, EndoPredict can guide treatment decisions on both the need for chemotherapy, as well as extended endocrine therapy. For more information, please visit: www.endopredict.com.

On February 15, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported the presentation of updated preliminary results from its Phase 2 clinical trial of its lead product candidate, tipifarnib, in patients with head and neck squamous cell carcinomas (HNSCC) with HRAS mutations (Press release, Kura Oncology, FEB 15, 2018, View Source [SID1234524150]).

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The results are being presented by Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center at the 2018 Multidisciplinary Head and Neck Cancers Symposium, taking place today in Scottsdale, Arizona. A copy of the poster is available online at www.kuraoncology.com.

Nine patients with HRAS mutant HNSCC had been enrolled in the Phase 2 trial as of the February 8, 2018 data cutoff date. Five out of the six evaluable patients achieved a confirmed, partial response as defined by standard RECIST criteria for an overall response rate of 83% (36-99.6%, 95%CI), including durable responses of more than 18 months in two patients. The sixth evaluable patient experienced tumor shrinkage and prolonged disease stabilization. Three additional patients were enrolled since the last update in October 2017, however, none of the three additional patients was evaluable as of the February 8th data cutoff date; two are off study and one was still too early for disease assessment.

"We continue to be very encouraged by the high level of clinical activity of tipifarnib observed in patients with HRAS mutant HNSCC," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "In addition to rapid responses in patients who do not appear to benefit from current standards-of-care, we are also seeing dramatic resolution of disfiguring and often painful lesions. We are continuing to enroll patients in the ongoing Phase 2 trial while we gather input from regulatory agencies on the design of a potential registrational trial of tipifarnib in HRAS mutant HNSCC anticipated to be initiated later this year."

All patients joined the trial upon progression from at least one line of therapy, including chemotherapy, cetuximab or immune therapy, with patients having experienced a median of two prior therapies (range, 1-4). Response rates for the three agents approved for treatment of HNSCC in the second line are in the range of 13-16%, with a median progression-free survival of approximately 2 months and a median overall survival of up to 7.5 months.

Tipifarnib was generally well-tolerated in the trial. Adverse events observed are consistent with the known safety profile of tipifarnib.

In September 2017, Kura announced that the Phase 2 trial in HRAS mutant HNSCC had achieved its primary efficacy endpoint prior to the completion of enrollment. The trial protocol required four confirmed, partial responses, per RECIST 1.1 criteria, out of 18 patients to meet its primary endpoint.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib. In addition to its development program in solid tumors with HRAS mutations, Kura has identified potential biomarkers of activity for tipifarnib in hematologic malignancies, including peripheral T-cell lymphomas (PTCL), myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML).

On February 15, 2018 Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the fourth quarter and full year ended December 31, 2017, and provide a general business overview on Wednesday, February 28, 2018, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332869 [SID1234524013]).

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Conference Call Details
The live conference call on Wednesday, February 28, 2018, at 4:30 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 4893459. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

On 15 February, 2018 ISA Pharmaceuticals B.V. (‘ISA’), a clinical-stage immunotherapy company, and Scancell Holdings plc, (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, reported that they have entered into a worldwide licensing and collaboration agreement to use ISA’s AMPLIVANT adjuvant technology for the manufacturing, development and commercialisation of Scancell’s first Moditope development candidate, Modi-1 (Press release, ISA Pharmaceuticals, FEB 15, 2018, https://www.isa-pharma.com/isa-pharmaceuticals-and-scancell-enter-collaboration-agreement-for-the-manufacturing-development-and-commercialisation-of-modi-1-amplivant-combination/ [SID1234612392]). This partnership has the potential to provide a new treatment option for patients with triple negative breast cancer, ovarian cancer, sarcomas, and other solid tumours.

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Under the terms of this agreement, ISA has granted Scancell an exclusive worldwide license to manufacture, develop and commercialise the AMPLIVANT:Modi-1 conjugate therapy and will contribute know-how and expertise related to AMPLIVANT. Clinical studies will be conducted by Scancell and are expected to commence in H1 2019.

In return, ISA will receive an upfront payment from Scancell and is entitled to milestone and royalty fees following achievement of certain criteria as defined in the agreement. Financial details were not disclosed.

Previous pre-clinical data demonstrated that conjugation of the Modi-1 peptides to AMPLIVANT enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour re-challenge.

ISA’s AMPLIVANT technology can be applied to any type of targeted immunotherapy, significantly enhancing its efficacy. It is based on a proprietary and synthetic small molecule TLR1/2 ligand with enhanced immunostimulatory activity that can be chemically coupled to the respective immunotherapeutic. AMPLIVANT conjugates allow lower dosing with higher efficacy through better dendritic cell antigen processing and presentation, as well as enhanced T cell priming.

Scancell’s Moditope platform acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes. This technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system.

"This collaboration is an important step to advance new adjuvant technologies such as AMPLIVANT to clinical-stage programmes and bring patients better treatments," said Ronald Loggers, CEO of ISA Pharmaceuticals. "The partnership will further validate the power of AMPLIVANT conjugates for use in therapeutic cancer vaccines that carry a variety of epitopes, including post-translationally modified epitopes such as Scancell’s Moditope products."

Cliff Holloway, CEO of Scancell, commented: "This collaboration with ISA Pharmaceuticals is an important step in the continued development and commercialisation of our first Moditope immunotherapy, Modi-1, which has the potential to treat patients with triple negative breast cancer, ovarian cancer and sarcoma who are resistant to other immunotherapies. Our pre-clinical studies have demonstrated Modi-1 induces potent anti-tumour responses and significant improvements in survival. We believe that combining Modi-1 with an enabling adjuvant technology such as AMPLIVANT has the potential to significantly enhance its efficacy in patients and we are looking forward to moving this important and novel therapy into the clinic in the first half of 2019."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).