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Roche to present new data from its oncology portfolio at the 2017 European Society for Medical Oncology (ESMO) Congress

On August 30, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new results from a number of studies across 18 approved and investigational medicines will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from 8-12 September in Madrid, Spain. These include phase III results from Roche’s targeted medicines portfolio, including Zelboraf and Alecensa, updates from our cancer immunotherapy development programme across multiple tumour types and important new insights into the biology of cancer that will help further our understanding of this highly complex disease.

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"Progress against cancer is accelerating as our understanding of the disease is enhanced by more sophisticated diagnostics, leading to increasingly tailored treatment approaches," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Continuing this progress will require both incremental and ground-breaking advancements as we collectively pursue cures for the many types of this incredibly complex disease. At ESMO (Free ESMO Whitepaper), we are proud to share data from across our broad cancer programme and we look ahead to an unprecedented number of key milestones over the next 12 months."

First results from the phase III BRIM8 study of Zelboraf for adjuvant (after surgery) treatment of BRAF V600 mutation-positive melanoma will be presented during ESMO (Free ESMO Whitepaper)’s Presidential Symposium on Monday 11 September 2017.

Additional highlights from the Roche oncology portfolio include new data from the phase III ALEX study investigating Alecensa in anaplastic lymphoma kinase (ALK)-positive NSCLC in the first-line setting. These new data further characterise the impact of Alecensa treatment on lung cancer that has the potential to, or has, spread to the central nervous system, building on the study’s positive primary results that were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting earlier this year. In addition, Roche will present new results from the phase III ALUR study of Alecensa in ALK-positive advanced NSCLC that compared Alecensa to chemotherapy in people who had been previously treated with chemotherapy as well as crizotinib.

Results from the phase II LORELEI study1 evaluating neoadjuvant (pre-surgery) use of taselisib in HER2-negative/oestrogen receptor (ER)-positive early breast cancer will provide additional insights into the potential role of PI3K inhibition in HER2-negative/ER-positive disease. These data from BRIM8, ALEX, ALUR, and LORELEI are included in the official ESMO (Free ESMO Whitepaper) press programme.

Roche will also present updates on the progress made in the understanding of the biology and immunology of cancer, including data generated in collaboration with Foundation Medicine. At ESMO (Free ESMO Whitepaper), data will be presented for the first time for a blood-based assay that is used to measure tumour mutational burden (TMB). Measuring TMB by comprehensive genomic profiling summarises how many mutations are present in a person’s tumour and may be a way to predict responses to certain cancer immunotherapies. The validation study being presented at ESMO (Free ESMO Whitepaper) was conducted using samples from the phase II POPLAR and phase III OAK studies of TECENTRIQÒ (atezolizumab) and provides initial, retrospective evidence of an association between TMB in the blood (bTMB) and TECENTRIQ activity. These early data will inform ongoing and future prospective research to better understand the role of both TMB and bTMB as it relates to treatment with cancer immunotherapy.

Follow Roche on Twitter via @Roche and keep up to date with ESMO (Free ESMO Whitepaper) 2017 congress news and updates by using the hashtag #ESMO17.

For more information on Roche’s approach to cancer, visit Roche.com.
Overview of key presentations featuring Roche medicines at ESMO (Free ESMO Whitepaper) 2017
About Roche in Oncology

Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); TECENTRIQ (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

In addition to Roche’s innovative portfolio of cancer medicines, Roche is constantly developing new diagnostic tests that will have a significant impact on disease management for cancer patients. Within the Roche Group there are more than 350 pharmaceutical and diagnostic collaborations, far more than half of which are in the field of oncology.

With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreatic and lung cancer, as well as a range of tissue and molecular oncology tests that contribute to personalised cancer care today, Roche is leading a new era of innovation in the fight against cancer.

Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

On August 30, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriah(TM)(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer (Press release, Novartis, AUG 30, 2017, View Source [SID1234520344]). Kymriah is the first therapy based on gene transfer approved by the FDA.

"At Novartis, we have a long history of being at the forefront of transformative cancer treatment," said Joseph Jimenez, CEO of Novartis. "Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care."

"We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program," said Bruno Strigini, CEO of Novartis Oncology. "As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated."

The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for Kymriah. The REMS program serves to inform and educate healthcare professionals about the risks that may be associated with Kymriah treatment. To support safe patient access, Novartis is establishing a network of certified treatment centers throughout the country which will be fully trained on the use of Kymriah and appropriate patient care.

There has been an urgent need for novel treatment options that improve outcomes for patients with relapsed or refractory (r/r) B-cell precursor ALL, whose prognosis is poor. Patients often undergo multiple treatments including chemotherapy, radiation, targeted therapy or stem cell transplant, yet less than 10% of patients survive five years [2], [3].

Kymriah is an innovative immunocellular therapy that is a one-time treatment. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. In 2012, Novartis and the University of Pennsylvania (Penn) entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

"This therapy is a significant step forward in individualized cancer treatment that may have a tremendous impact on patients’ lives," said Carl June, MD, the Richard W. Vague Professor of Immunotherapy, Director of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine, who is a pioneer of this new treatment. "Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of hematologic and other cancer types."

In close collaboration with Novartis and Penn, Children’s Hospital of Philadelphia (CHOP) was the first institution to investigate Kymriah in the treatment of pediatric patients leading the single site trial.

"Tisagenlecleucel is the first CAR-T therapy to demonstrate early, deep and durable remission in children and young adults with relapsed or refractory B-cell ALL," said Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at Penn, and Director of the Cancer Immunotherapy Frontier Program at Children’s Hospital of Philadelphia (CHOP). "We’ve never seen anything like this before and I believe this therapy may become the new standard of care for this patient population."

Novartis is committed to ensuring eligible patients have access to Kymriah, and is working to ensure payers understand the value of Kymriah and provide coverage for patients. To address the unique aspects of the therapy, Novartis has also developed various patient access programs to support safe and timely access for patients. Novartis is also providing traditional support to patients by helping them navigate insurance coverage and providing financial assistance for those who are uninsured or underinsured.

Novartis plans additional filings for Kymriah in the US and EU later this year, including applications with the FDA and European Medicines Agency (EMA), for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL). Additional filings beyond the US and EU are anticipated in 2018.

Groundbreaking Collaboration with the Centers for Medicare and Medicaid Services
Novartis also announced a novel collaboration with the United States Centers for Medicare and Medicaid Services (CMS) focused on improving efficiencies in current regulatory requirements in order to deliver value-based care and ensure access for this specific patient population.

This approach is intended to include indication-based pricing for medicines and supports payments for a medicine, such as Kymriah for its initial indication, based on the clinical outcomes achieved, which would eliminate inefficiencies from the healthcare system. Other value-based approaches related to future indications for Kymriah and CAR-T cell therapies are under discussion.

Furthermore, Novartis is collaborating with CMS to make an outcomes-based approach available to allow for payment only when pediatric and young adult ALL patients respond to Kymriah by the end of the first month. Future potential indications would be reviewed for the most relevant outcomes-based approach.

"Novartis has been at the forefront of outcomes-based pricing and is very pleased to work with CMS on this first-of-its-kind collaboration with a technology that has the potential to transform cancer care," said Joseph Jimenez, CEO of Novartis. "We look forward to continuing to work with CMS to potentially expand this approach to other products and disease states."

New Data for Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Durable Responses in Patients with Advanced Melanoma

On August 30, 2017 Incyte Corporation (Nasdaq:INCY) reported that the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) has published an abstract (#1214O) containing new and updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with the anti-PD-1 KEYTRUDA (pembrolizumab), marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in patients with advanced melanoma (Press release, Incyte, AUG 30, 2017, View Source [SID1234520343]).

"We are encouraged by these additional data from our ECHO-202 trial, which demonstrate robust and durable responses in patients with advanced melanoma treated with the combination of epacadostat and KEYTRUDA," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These results further underscore the potential of this novel immunotherapy combination, and we look forward to reporting more detailed results from this study at ESMO (Free ESMO Whitepaper) next month."

Key Findings from the ECHO-202 Advanced Melanoma Cohort
Results of efficacy evaluable patients (N=54) as of February 27, 2017 include:

ECHO-202 Overall Response Rates (ORR), Disease Control Rates (DCR) and Durability of Response (DoR) in Advanced Melanoma
n/N
(%) All Patients
Treatment-Naïve
Advanced Melanoma
Patients

Treatment-Naïve
Advanced Melanoma
Patients
(epacadostat 100 mg BID)
ORR
30/54
(56)
25/45
(56)
18/30
(60)
8 CR (15)
22 PR (41)
6 CR (13)
19 PR (42)
2 CR (7)
16 PR (53)
DCR
42/54
(78)
35/45
(78)
Not yet reported
DoR 28/30 responses ongoing
Median (range) duration of response: 287.5+ (1+ to 763+) days

Across all efficacy-evaluable advanced melanoma patients, median progression-free survival (PFS) was 12.4 months, with PFS rates of 70 percent, 54 percent, and 50 percent at 6 months, 12 months, and 18 months respectively. In patients who were treatment-naïve for advanced disease, median PFS has not been reached, with landmark PFS rates of 68 percent, 52 percent, and 52 percent at 6 months, 12 months, and 18 months respectively.

Epacadostat in combination with KEYTRUDA was well-tolerated. The most common (≥15 percent) all grade treatment-related adverse events (TRAEs) were fatigue (39 percent), rash (33 percent), pruritus (27 percent), and arthralgia (16 percent). Grade ≥3 TRAEs were observed in 17 percent of patients; the most common were increased lipase (n=4), rash (n=3), and increased amylase (n=2). Three patients discontinued for TRAEs. No treatment-related deaths occurred.

The abstract was made available today on the ESMO (Free ESMO Whitepaper) Congress website at View Source

Updated data from ECHO-202 will be highlighted in an oral presentation on Saturday, 9 September 2017 from 15:00 – 15:15 CET at the ESMO (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain. Following the presentation, Incyte will host an investor conference call and webcast at 17:00 CET (11:00 a.m. ET) on 9 September 2017—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of www.incyte.com.

About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA. Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment is complete for the Phase 1 dose escalation (epacadostat 25, 50, 100 mg BID + KEYTRUDA 2 mg/kg IV Q3W and epacadostat 300 mg BID + KEYTRUDA 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + KEYTRUDA 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit View Source

About ECHO
The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies are evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors in a broad range of solid tumor types as well as hematological malignancies. ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind, placebo-controlled study investigating KEYTRUDA in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also ongoing and fully recruited. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)
The immunosuppressive effects of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme activity on the tumor microenvironment help cancer cells evade immunosurveillance. Epacadostat is an investigational, highly potent and selective oral inhibitor of the IDO1 enzyme. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck and bladder cancer. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitors KEYTRUDA or nivolumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

Puma Biotechnology Announces Publication of Abstracts for ESMO 2017

On August 30, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of two abstracts on its drug neratinib that will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, which will be held September 8 – 12 in Madrid, Spain (Press release, Puma Biotechnology, AUG 30, 2017, View Source [SID1234520342]). Abstracts are available to the public online on the ESMO (Free ESMO Whitepaper) website: www.esmo.org.

Abstract #1490: Neratinib after trastuzumab-based adjuvant therapy in early stage HER2-positive breast cancer: 5-year analysis of the Phase III ExteNET trial.
The abstract will be presented as a proffered paper oral session on Friday, September 8.

Abstract #177P: Effects of neratinib on health-related quality of life in early stage HER2-positive breast cancer.
The abstract will be displayed as a poster on Monday, September 11.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.

U.S. Approval of Neratinib (NERLYNX)

Neratinib was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

Indication

NERLYNX is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

The full prescribing information for NERLYNX is available at www.NERLYNX.com . The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

Important Safety Information

There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.

Diarrhea

Diarrhea is a common side effect of NERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:

You should start taking loperamide with your first dose of NERLYNX.
Keep taking loperamide during the first 2 cycles (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide.
While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or if you have diarrhea that does not go away.
Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness or fever.

Liver Problems

Changes in liver function tests are common with NERLYNX. The patient’s doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach area (abdomen), fever, rash, itching or yellowing of your skin or whites of your eyes.

Pregnancy

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.

Common side effects in patients treated with NERLYNX

In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood test results, nail problems, dry skin, abdominal distention, weight loss and urinary tract infection.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or View Source . Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).

Please see Full Prescribing Information, available at www.NERLYNX.com .

Immune Design Announces New CMB305 + Checkpoint Inhibitor Topline Data from an Upcoming Presentation at the ESMO 2017 Congress

Key Findings from the ECHO-202 Advanced Melanoma Cohort
Results of efficacy evaluable patients (N=54) as of February 27, 2017 include:

The abstract was made available today on the ESMO (Free ESMO Whitepaper) Congress website at View Source