On June 5, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data for TECENTRIQ and updates from across its extensive cancer immunotherapy clinical development programme will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on 2 June – 6 June in Chicago, Illinois, United States (Press release, Hoffmann-La Roche, JUN 3, 2017, View Source [SID1234519439]). Data from phase I, II and Phase III studies presented at ASCO (Free ASCO Whitepaper) 2017 suggest that TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

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Data from a study of TECENTRIQ plus Avastin in metastatic Renal Cell Carcinoma (mRCC) supports a scientific rationale for combining TECENTRIQ with Avastin including its potential to increase infiltration (trafficking) of T-cells into tumours and other immune-modulatory properties. New data will also be presented for TECENTRIQ as a monotherapy from the OAK trial, which represent the first treatment-beyond-progression data from a Phase III study of cancer immunotherapy in advanced lung cancer (NSCLC). Updated data will also be presented from the Phase Ib study of TECENTRIQ in combination with chemotherapy for people with advanced NSCLC. Two Phase Ib studies in melanoma combining TECENTRIQ plus Cotellic (cobimetinib) and TECENTRIQ plus Cotellic plus Zelboraf (vemurafenib) showed that the addition of Zelboraf and/or Cotellic may alter the tumour micro environment, enhancing the anti-tumour activity of TECENTRIQ.

"By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients, and at ASCO (Free ASCO Whitepaper) 2017 we are presenting data from a range of medicines and combinations that we believe have this potential."
Kidney cancer (Renal Cell Carcinoma RCC)

IMmotion150 is a global, multicentre Phase II study that was designed to evaluate the efficacy and safety of TECENTRIQ plus Avastin, TECENTRIQ alone or sunitinib alone in 305 patients with previously untreated, locally advanced or mRCC. After progression on the sunitinib or TECENTRIQ arms of the study, 77% and 75% of patients crossed over to TECENTRIQ plus Avastin treatment, respectively.

Clinical activity of TECENTRIQ plus Avastin was seen in crossover patients regardless of first line TECENTRIQ or sunitinib therapy or response to first line therapy, further supporting this combination as a potential treatment option. Specifically, TECENTRIQ plus Avastin resulted in an Overall Response Rate (ORR) of 26% in all-crossover patients (28% in crossover post-sunitinib; 24% in crossover post-TECENTRIQ patients) with a median Progression Free Survival (PFS) of 8.8 months in all-crossover patients. There were no new safety signals observed in the crossover treated patients.

A Phase III study, IMmotion151, in a similar population is expected to provide initial results in early 2018.
IMmotion150: A Phase II trial in untreated metastatic renal cell carcinoma (mRCC) patients (pts) of atezolizumab (atezo) and bevacizumab (bev) vs and following atezo or sunitinib (sun). Oral abstract 4505 Monday 5 June, 08:00 – 11:00 CDT

Lung cancer
In the Phase III OAK trial, which studied the impact of TECENTRIQ treatment beyond radiologic disease progression (PD), showed that a continuation of TECENTRIQ treatment after PD resulted in promising clinical benefit. The study design allowed patients randomised to TECENTRIQ to continue treatment beyond PD, as assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, if the patient was considered to be deriving clinical benefit from treatment. TECENTRIQ could be continued until there was loss of clinical benefit according to the investigator’s clinical judgement.

Patients in the TECENTRIQ arm who continued TECENTRIQ therapy beyond PD had a prolonged clinical benefit, 12.7 months Overall Survival (OS) (95% CI 9.3–14.9) compared with 8.8 months OS (6.0 – 12.1) for those treated with other anti-cancer treatments post PD. Tumour target lesion responses and stabilisation post-PD were seen across all subgroups of programmed death-ligand 1 (PD-L1) expression. These data support the treatment strategy of continuing TECENTRIQ beyond PD until loss of clinical benefit in patients, regardless of the level of PD-L1 expression.
Impact of atezolizumab (atezo) treatment beyond disease progression (TBP) in advanced NSCLC: Results from the randomised phase III OAK study. Oral abstract TPS5090
Tuesday 6 June, 09:45 – 12:45 CDT

The updated efficacy and safety data for Arms C–E of our phase Ib GP28328 study are encouraging for TECENTRIQ in combination with various chemotherapies. The primary endpoint of the study was safety and TECENTRIQ was well tolerated when combined with various chemotherapies.
Updated efficacy and safety data table for TECENTRIQ in combination Arms C–E

The confirmed ORRs and mature OS data provide further evidence for a synergy between the anti-tumour activity of TECENTRIQ and chemotherapy.
Abstract 9092, Poster Board: #418. Lung Cancer—Non-Small Cell Metastatic
Saturday 6 June, 08:00 – 11:30 CDT

Melanoma
Updated study results from two Phase Ib studies combining TECENTRIQ plus Cotellic (cobimetinib) and, TECENTRIQ plus Cotellic plus Zelboraf (vemurafenib) showed improved ORR and PFS after a longer follow up. Both combination studies demonstrated a manageable safety profile.

Based on the results of the Phase 1b studies both combinations are now in Phase III clinical trials. The TECENTRIQ plus Cotellic plus Zelboraf combination will be investigated in people with untreated BRAFV600‑mutant unresectable metastatic melanoma while the TECENTRIQ plus Cotellic combination will be studied in people with untreated, unresectable metastatic BRAF wild-type melanoma.
Atezolizumab (A) + cobimetinib (C) + vemurafenib (V) in BRAFV600-mutant metastatic melanoma (mel): Updated safety and clinical activity. Abstract 3063
Monday 5 June, 08:00 – 11:30 CDT
Atezolizumab (A) + cobimetinib (C) in metastatic melanoma (mel): Updated safety and clinical activity.
Abstract 3057
Monday 5 June, 8:00 – 11:30CDT
Pipeline
Data from two studies will be presented that demonstrate the potential of TECENTRIQ in combination with novel cancer immunotherapies. These studies include a Phase I dose escalation study evaluating the T-cell bispecific (CEA- TCB) antibody as a single agent or in combination with TECENTRIQ in patients with metastatic colorectal cancer and a Phase Ib dose-escalation study evaluating the combined inhibition of TECENTRIQ plus IDO1 (GDC-0919) in patients with locally advanced or metastatic solid tumours and
Monotherapy data will also be presented from a Phase Ia study of TECENTRIQ in advanced/recurrent endometrial cancer (rEC), a patient population for whom the prognosis remains poor. The study is evaluating clinical activity and safety. Results show that TECENTRIQ has a favourable safety profile in rEC, with durable clinical benefit seen in some patients. Clinical benefit appeared to increase with higher PD-L1 expression, suggesting a link between PD-L1 status and response.

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2017 scientific programme, the company’s wider progress in cancer care and key data being presented at the conference will be featured at a Roche investor briefing on Monday, 5 June 2017 at 17:15 CDT. This event is independently organised by Roche and is open to analysts attending the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting. To register for the Roche investor briefing, please use the following link: http://roche.cvent.com/d/85qzfy.

To learn more about Roche’s personalised cancer immunotherapy programme and Roche’s contribution to ASCO (Free ASCO Whitepaper) 2017, please follow Roche on Twitter via @Roche. You can keep up to date with ASCO (Free ASCO Whitepaper) 2017 Annual Meeting news and updates by using the hashtag #ASCO17.
Overview of Roche cancer immunotherapy data being presented at ASCO (Free ASCO Whitepaper) 2017

On June 2, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported the results from a Phase 2 trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer (Press release, NewLink Genetics, JUN 2, 2017, View Source [SID1234519388]).

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Top line data from the study show that the trial did not meet its pre-specified endpoints of a statistically significant difference between the two treatment groups as to progression-free survival, overall survival or objective response rate.

"As demonstrated by multiple studies that have been reported since the start of this clinical trial, breast cancer unfortunately remains a challenging disease in immuno-oncology," said Primary Investigator Hatem Soliman MD, Associate Member Breast, Tumor Biology, and Immunology Departments, Chair Clinical Research Advisory Committee, H. Lee Moffitt Cancer Center and Research Institute, Associate Professor, Division of Oncologic Sciences University of South Florida.

In this study, NLG2101, 169 first line metastatic breast cancer patients were selected to receive either docetaxel or paclitaxel by their treating physicians. Once the choice of backbone chemotherapy was made, patients were then randomized to receive either indoximod or placebo.

"We would like to thank all the patients, families, investigators, and research teams who supported the completion of this trial," said Charles J. Link, Jr., M.D., Chairman and CEO of NewLink Genetics. "Independent of these results, we continue to be highly encouraged by indoximod as an IDO pathway inhibitor and look forward to future opportunities to share data from ongoing trials in multiple cancer types including melanoma, prostate cancer, acute myelogenous leukemia, and pancreatic cancer."

Full results of the trial will be presented at an upcoming academic meeting.

On June 2, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported the presentation of findings in patients with metastatic melanoma in the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada (Press release, Dynavax Technologies, JUN 2, 2017, View Source [SID1234519437]). Results evaluating 19 patients for efficacy and 22 patients for safety were presented in a poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago:

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• In 7 anti-PD-1/L1-naïve patients, SD-101 used in combination with KEYTRUDA resulted in an overall response rate (ORR) of 100%, with a complete response (CR) rate of 29%. This is a meaningful increase over use of KEYTRUDA alone, which has already shown a 33% ORR, with a 6% CR.1

• In 12 patients with advanced (stage IIIc/IV) melanoma who had previously failed on anti-PD-1 treatment, introduction of SD-101 resulted in tumor shrinkage in 42% of patients, with 17% having a partial response (PR), indicating an anti-tumor immune response generated by SD-101.

• The combination of SD-101 and KEYTRUDA in this study, mobilized both innate and adaptive immune response in study participants.

• Tumor shrinkage was observed in non-injected visceral lesions.

"Having 7 out of 7 patients naïve to anti-PD-1/L1 treatment responding is very encouraging," said Antoni Ribas, M.D., Ph.D., of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, and lead investigator. "These results are supported by tumor shrinkage in patients who had previously progressed on anti-PD-1 treatment and by confirmatory laboratory biomarker assessments in tumor biopsies. If these clinical results are sustained in the ongoing trial, this combination, which mobilizes both innate and adaptive immune responses in patients, could represent an important advancement in immuno-oncology."

SD-101 in combination with KEYTRUDA generally was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia. The study also includes biomarker assessments, suggesting that treatment with SD-101 and KEYTRUDA resulted in increased tumor-infiltrating lymphocytes and decreased Th2 in tumor biopsies, consistent with induction of an antitumor immune response.

Keytruda.com View Source

About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.

About SD-101
SD-101 is Dynavax’s proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. SD-101 is being studied for its multiple anti-tumor activities in innate immune cells and activation of plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On June 2, 2017 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) reported the schedule of presentations featuring TG-1101 and TGR-1202 at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held this week, June 2 – 6, 2017, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, JUN 2, 2017, View Source [SID1234519352]).

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Know more, wherever you are:
Latest on Cancer Drug Development at ASCO (Free ASCO Whitepaper), book your free 1stOncology demo here.

Oral Presentation:

Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
– Abstract Number: 7504
– Date & Time: Saturday, June 3, 2017 3:00 PM – 6:00 PM CT
– Presentation Time: 4:12 PM CT
– Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
– Presenter: Jeffrey P. Sharman, MD

Poster Discussion Presentation:

Title: Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL
– Abstract Number: 7511
– Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT (Poster Viewing); 1:15 PM-2:30 PM CT (Poster Discussion)
– Session Title: Poster Discussion Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
– Presenter: Loretta Nastoupil, MD

Trials in Progress Poster Presentation:

Title: KI intolerance study: A phase 2 study to assess the safety and efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy
– Abstract Number: TPS7569
– Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT
– Session Title: Poster Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
– Presenter: Colleen Dorsey, BSN, RN

Abstracts are available online and can be accessed at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations now beginning promptly at 7:05pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event.

On June 1, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that Tito Serafini, Ph.D., President, Chief Executive Officer, and Co-Founder, will present at the Jefferies 2017 Global Healthcare Conference on Thursday, June 8, 2017 at 8:00 a.m. Eastern Time in New York, NY (Press release, Atreca, JUN 1, 2017, View Source [SID1234522952]). Dr. Serafini will provide an overview of Atreca’s technologies, programs and progress.

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