On May 16, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive data from the Phase I/II STARTRK-NG study, evaluating the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions (Press release, Hoffmann-La Roche, MAY 16, 2019, View Source [SID1234536388]). The study showed entrectinib shrank tumours (objective response rate; ORR) in all children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumours (11 of 11 patients), including two patients achieving a complete response.1 Of the 11 patients, five patients with primary high-grade tumours in the central nervous system (CNS) had an objective response, including one patient with a complete response.1 The safety profile of entrectinib was consistent with that seen in previous analyses.1 Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on Sunday, 2 June, 2019, from 8:00 – 8:12 am CDT (Abstract 10009), and was part of yesterday’s official ASCO (Free ASCO Whitepaper) presscast.

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"We are encouraged by the results we have seen with entrectinib in children with paediatric and adolescent cancers, including those with tumours in the brain," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The STARTRK-NG study underscores the importance of combining comprehensive genomic profiling with targeted therapies and supports our approach to providing people with personalised medicines developed specifically for their type of cancer."

Additional data for entrectinib across different tumour types and patient populations will also be presented at ASCO (Free ASCO Whitepaper), highlighting the company’s unique approach to personalised healthcare through advances in targeted therapies, diagnostics and data analytics:

Initial results from an integrated analysis of the Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, evaluating the efficacy of entrectinib in adults with solid tumours and CNS metastases, will be presented on Saturday, 1 June, 2019, in a poster session from 3:00 – 4:30 pm CDT (Abstract 3017).
Results from a Real World Data study, evaluating time-to-treatment discontinuation and progression-free survival as endpoints for comparative efficacy analysis of clinical trials of entrectinib and crizotinib for the treatment of people with ROS1-positive non-small cell lung cancer (NSCLC), will be presented during a poster session on Sunday, 2 June, 2019, from 8:00 – 11:00 am CDT (Abstract 9070).
The FDA recently granted Priority Review for entrectinib for both the treatment of paediatric and adult patients with NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic ROS1-positive NSCLC.2 These NDAs are based on results from the integrated analysis of the Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the STARTRK-NG study. The FDA is expected to make a decision on approval by 18 August, 2019.2

About the STARTRK-NG study
STARTRK-NG is a Phase I/II open-label dose-escalation and expansion study evaluating the safety and efficacy of entrectinib in children and adolescent patients with no curative first-line treatment option, recurrent or refractory extracranial solid tumours or primary CNS tumours, with or without NTRK, ROS1 or ALK fusions.1 Response, assessed by Investigator, was classified as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) using Response Assessment in Neuro-Oncology (RANO) for CNS tumours, Response Evaluation Criteria in Solid Tumors (RECIST), and Curie score (CS) for NBL.1 The study enrolled 29 children and adolescents aged 4.9 months through to 20 years (median age of 7 years) who had recurrent or refractory solid tumours, and 28 were evaluated for response.1 Of the 28 children and adolescents evaluated, 11 children were identified to have tumours with NTRK, ROS1 or ALK fusions and one with ALK F1174L-mutated neuroblastoma (NBL).1 A summary of the results are included below.

Complete responses were observed in 2 patients with tumours harbouring NTRK and ALK fusions: 1 with an NTRK fusion-positive primary CNS tumour and 1 with an ALK fusion-positive inflammatory myofibroblastic tumour. Another complete response was observed in 1 neuroblastoma patient with an ALK F1174L mutation.1
Partial responses were observed in 9 patients, 3 unconfirmed at the time of the clinical cut-off date, across NTRK, ROS1 and ALK fusion-positive primary CNS (n=4) and extracranial (n=5) solid tumours.1
Median duration of therapy for confirmed fusion-positive responders was 10.51 months (3.8 to 17.7 months), and median time to response was 1.89 months (1 to 1.9 months).1
The safety profile of entrectinib was consistent with that seen in previous analyses. Treatment-related adverse events were most frequently National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Grade 1 or 2, leading to discontinuation in 6.9% of patients.1
About NTRK fusion-positive cancer
Neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TRKA/TRKB/TRKC) that can activate signaling pathways involved in proliferation of certain types of cancer. NTRK gene fusions are tumour-agnostic, meaning they are present in tumours irrespective of site of origin. These fusions have been identified in a broad range of solid tumour types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.3

About entrectinib
Entrectinib (RXDX-101) is an investigational, oral medicine in development for the treatment of locally advanced or metastatic solid tumours that harbour NTRK1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.4,5 Entrectinib can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.4,5 Entrectinib is being investigated across a range of solid tumour types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.2,3

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the FDA; Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake designation by the Japanese health authorities for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.2

On May 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 15 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2019 in Amsterdam, the Netherlands, taking place June 13-16, 2019 (Press release, Genmab, MAY 16, 2019, View Source [SID1234536411]). A list of accepted Industry-sponsored abstracts featured at the congress includes 14 daratumumab abstracts, four of which were accepted for oral presentations, including a presentation of the Phase III CASSIOPEIA data, which the Scientific Program Committee of the EHA (Free EHA Whitepaper) selected for presentation during the Presidential Symposium, which showcases abstracts that represent innovative research in hematology. In addition, one abstract features Genmab’s proprietary DuoBody-CD3xCD20 product. The abstracts have been published on the EHA (Free EHA Whitepaper) website and may be accessed via www.ehaweb.org.

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"The presentation of impressive pre-clinical data on our DuoBody-CD3xCD20 program exemplifies how Genmab is advancing its proprietary product pipeline using our strong expertise in antibody drug development to create truly differentiated products to help patients with hematologic malignancies. We are also very pleased that the EHA (Free EHA Whitepaper) has selected the CASSIOPEIA data for presentation during the prestigious Presidential Symposium as it reinforces Genmab’s impactful contribution to multiple myeloma treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Industry-Sponsored Abstracts are as follows:

DuoBody-CD3xCD20:
Potent Anti-tumor Activity of DuoBody-CD3xCD20 in Pre-clinical Models In Vitro and In Vivo – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone (VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results – Oral presentation, Friday, June 14, 3:45 PM – 4:00 PM CEST

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA – Oral presentation, Saturday, June 15, 4:45 PM – 5:00 PM CEST

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Saturday, June 15, 11:30 AM – 11:45 AM CEST

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA – Oral presentation, Saturday, June 15, 5:00 PM – 5:15 PM CEST

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

On May 16, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that a trial in progress (TiP) poster will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from May 31 to June 4, 2019 (Press release, Replimune, MAY 16, 2019, View Source [SID1234536427]). The abstract is available on the ASCO (Free ASCO Whitepaper) website (View Source). The poster will describe the design and current status of the Company’s ongoing Phase 1/2 clinical trial in approximately 150 patients of RP1 alone and in combination with nivolumab anti-PD1 therapy in four solid tumor types, and will be made available on the Company’s website at the time of presentation.

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Details of Replimune’s poster presentation:

Abstract Title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors (Abstract TPS2671)

Session Title: Developmental Immunotherapy and Tumor Immunobiology

Session Date and Time: Saturday June 1st, 8:00am-11:00am CDT

Location: McCormick Place, Exhibit Hall A, Poster Board #301b

About RP1
RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

On May 16, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that ALX148 clinical results have been selected for presentation in the Poster Discussion Session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, May 31 – June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, ALX Oncology, MAY 16, 2019, View Source [SID1234536443]).

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ALX148 Presentation Information

Title: A phase 1 study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy (Abstract #2514).

Poster Discussion Session: Developmental Immunotherapy and Tumor Immunobiology, Advances in Immune Checkpoint Inhibition

Date: Saturday, June 1

Time: 1:15 p.m. – 1:27 p.m.

Location: Hall D1

Poster Display Session: Developmental Immunotherapy and Tumor Immunobiology

Date: Saturday, June 1

Time: 8:00 a.m. – 11:00 a.m.

Location: Hall A

On May 16, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, Hoffmann-La Roche, MAY 16, 2019, View Source [SID1234536389]).

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"Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia."

The approval is based on the results of the randomised phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. Results showed the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by Independent Review Committee) by 67% compared to Gazyva plus chlorambucil, a current standard-of-care (HR=0.33; 95% CI 0.22-0.51; p<0.0001). Venclexta plus Gazyva showed deep and clinically meaningful responses characterised by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared to Gazyva plus chlorambucil (MRD-negativity of 57% vs. 17%) and peripheral blood (MRD-negativity of 76% vs. 35%). MRD-negativity means no cancer can be detected using a specific and highly sensitive test, defined as less than one CLL cell in 10,000 white blood cells.

Results of the study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The most common adverse reactions with Venclexta plus Gazyva were low white blood cell count, diarrhoea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.

The FDA rapidly reviewed and approved the supplemental New Drug Application (sNDA) under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programmes. This is the second regimen of Roche medicines approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The sNDA was also granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA previously granted Breakthrough Therapy Designation for Venclexta in combination with Gazyva for the treatment of previously untreated CLL with co-existing medical conditions. Additional submissions of the CLL14 data to health authorities around the world are ongoing.

Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche group, in the US and commercialised by AbbVie outside of the US.

About the CLL14 Study
CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta alongside six-month duration of Gazyva (Arm A) or six-month duration of Gazyva plus chlorambucil followed by an additional six-month duration of chlorambucil (Arm B). Arm A started with an initial cycle of Gazyva followed by a five-week Venclexta dose ramp-up to help reduce tumour burden. The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response (OR), complete response (with or without complete blood count recovery, CR/CRi), overall survival (OS), duration of response (DOR), event-free survival (EFS), time to next CLL treatment (TTNT) and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The most common adverse reactions with Venclexta plus Gazyva were low white blood cell count, diarrhoea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.
Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie, under the brand name Venclyxto, outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated CLL, two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.

About Gazyva/Gazyvaro (obinutuzumab)
Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About the German CLL Study Group (GCLLSG)
Founded in 1996 and headed by Michael Hallek, MD, the GCLLSG has been running various phase III, phase II and phase I trials in chronic lymphocytic leukaemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organisation supported by the German Cancer Aid (Deutsche Krebshilfe) www.dcllsg.de.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes polatuzumab vedotin, an anti-CD79b antibody drug conjugate; idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, and Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.