On February 14, 2020 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated commercial-stage biopharmaceutical company developing novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of TAZVERIK (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy (Press release, Epizyme, FEB 14, 2020, View Source [SID1234554364]). The FDA granted Priority Review and has designated the company’s application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

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"Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "If approved, we believe TAZVERIK could become an important new option for these patients and their physicians. We are thrilled with FDA’s acceptance of our application as an sNDA with Priority Review, for TAZVERIK for patients with relapsed or refractory FL. We look forward to working with the Agency during their review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable in bringing us to this point."

"On the heels of our first approval for TAZVERIK for epithelioid sarcoma last month and a successful launch into the market, this sNDA filing acceptance brings us one step closer to providing TAZVERIK to a larger patient population," said Robert Bazemore, chief executive officer of Epizyme. "The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme. We are actively building off our experience with our ES commercial launch, in order to seamlessly expand to an FL launch where we anticipate rapid market adoption, if approved."

Epizyme’s sNDA submission is based primarily on updated Phase 2 efficacy and safety data for TAZVERIK in this patient population, which were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated that treatment with TAZVERIK resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).

To support a full approval of TAZVERIK for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. The safety run-in portion of the trial is underway, and the company expects to advance into the efficacy portion of the Phase 1b/3 trial in 2020.

About TAZVERIK
TAZVERIK (tazemetostat) is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For the full prescribing information, please visit www.TAZVERIK.com.

On February 14, 2020 Noxopharm (ASX: NOX) is reported positive interim results from its LuPIN Phase 1/2 clinical trial (Press release, Noxopharm, FEB 14, 2020, View Source [SID1234554365]). The data was presented during a poster presentation at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers (GU) Symposium 2020 in San Francisco by St. Vincent’s Hospital Sydney.

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The LuPIN study is being conducted by St. Vincent’s Hospital Sydney and is evaluating Noxopharm’s lead drug candidate, Veyonda, in combination with 177Lu-PSMA-617, in 56 patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).

"Today’s results are highly encouraging for patients, for Noxopharm shareholders, and for the St. Vincent’s Hospital Sydney team," said Dr. Gisela Mautner, Noxopharm chief medical officer. "The study reported an unprecedented median overall survival of 17.1 months. In a patient group that normally would have a survival expectation of much less than this, such a result is astoundingly good. The combination treatment of Veyonda and 177Lu-PSMA-617 has delivered a clinically meaningful and strong anti-cancer effect in a high proportion of men and, importantly, continues to have an excellent safety profile."

All patients had received and failed two prior lines of therapy (chemotherapy and androgen-signaling inhibitors), and most patients (29 of 32) had failed a third line of therapy (another chemotherapy) prior to entering the trial.

"The study investigators at St. Vincent’s Hospital Sydney continue to do excellent work through the LuPIN trial and we are pleased to support them," Dr. Mautner added.

"Being able to deliver a meaningful anti-cancer response for at least 50% of patients with Stage 4 for any form of cancer would be a remarkable outcome," said Noxopharm CEO Dr. Graham Kelly. "But it is even more remarkable to do so in late-stage prostate cancer, where the disease typically involves a substantial number of secondaries in the skeleton, which are a significant and poorly accessible tumor load. A median overall survival of 17.1 months is remarkable for this novel radiosensitizing and immuno-oncology drug."

On February 14, 2020 OncoDNA ("OncoDNA or "the Company"), the healthcare technology company making precision medicine a reality, reported that it has completed a €19 million ($20 million) Series B equity financing (Press release, OncoDNA, FEB 14, 2020, View Source [SID1234554366]). The new funding will support rapid international growth, accelerate software development and hiring initiatives.

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The round was led by Vesalius Biocapital III and Swisscanto Invest by Zürcher Kantonalbank with the significant support of SFPI-FPIM. Historical shareholders together with CPH Bank, Inventures, Sambrinvest, Sofinim (Ackermans & Van Haaren) and SRIW have also participated. This represents another landmark achievement after the €8 million Series A fundraising closed in September 2016.

OncoDNA is now maximizing the fast and proper rollout of its oncology clinical decision support software OncoKDM with the objective of becoming the European leader in oncogenomic data interpretation and reporting to further support molecular laboratories, healthcare professionals and the pharma industry in their daily research and clinical practice.

Jean-Pol Detiffe, Founder & Chief Executive Officer at OncoDNA: "We are delighted to have successfully raised sufficient new capital from such quality investors who will enable us to grow and increase our support to oncologists and cancer patients with our data driven solutions. OncoDNA is already positioned as the European champion for cancer precision medicine as we built a worldwide network of more than several thousand oncologists. Our next move is to connect molecular laboratories to our advanced data interpretation tools, which we pride ourselves on now being possible thanks to the support of our new investors."

Guy Geldhof, Partner at Vesalius Biocapital III S.C.A. SICAR said: "We are excited about co-leading the Series B investment in OncoDNA. It is thrilling to work with a team that has both world class experience in genomic molecular profiling and a strong desire to serve patients by offering best-in-class support to oncology professionals. We are confident OncoDNA will accelerate the development and commercialization of its valuable new solutions, especially through closer collaborations with the biopharma industry, with the final objective of contributing to better healthcare."

Robert Schier, Partner at Swisscanto (CH) Private Equity Switzerland Growth I KmGK added: "OncoDNA has grown significantly over the past years and are continuing to add the necessary clinical expertise and know-how to act upon its mission. Its disruptive vision and highly integrated market approach make it to be the perfect candidate to rapidly become the European leader in oncology big data. We are delighted to partner with OncoDNA as we firmly believe the company contributes to both a more sustainable healthcare system and improved patient health outcomes."

"Considering our important investment in OncoDNA, alongside players like Vesalius Biocapital III and Swisscanto, we are convinced that the company has all the necessary means at a key moment of its development to successfully carry out appropriate projects to assist and support oncologists in prescribing the most optimal therapeutic treatments to patients. We are happy to count on the support of our colleagues from SRIW and Sambrinvest as historical stakeholders" concluded François Fontaine, at SFPI-FPIM.

On February 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that China National Medical Products Administration (NMPA) has approved Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Hoffmann-La Roche, FEB 14, 2020, View Source [SID1234554346]).

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"Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease."

Lung cancer is the most common cancer and the leading cause of cancer death in China.1 Overall, SCLC accounts for around 15% of all lung cancer cases and, with two-thirds of patients diagnosed at the ‘extensive’ stage, the prognosis for people with this form of the disease is poor.2 The average five-year survival for people with ES-SCLC is only 2%.3

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54–0.91; p=0.0069). The combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=5.2 versus 4.3 months; hazard ratio [HR]=0.77; 95% CI: 0.62–0.96; p=0.017).4 Follow-up analysis suggests that at 18 months the OS rate was 34% for people receiving the Tecentriq-based treatment versus 21% for people receiving chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq. The results represent the first clinically meaningful advance in the first-line treatment of ES-SCLC in more than 20 years.

In January 2020, the China NMPA also accepted the supplemental Biologics License Application (sBLA) for Tecentriq in combination with Avastin (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer, who have not received prior systemic therapy. The submission is based on the results from the Phase III IMbrave150 study, which met both of its co-primary endpoints, demonstrating statistically significant and clinically meaningful improvements in OS and PFS compared with current standard of care, sorafenib.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC. The study enrolled 403 people who were randomised equally (1:1) to receive:

Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm

During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS, as determined by the investigator using RECIST v1.1 and OS in the intention-to-treat (ITT) population.

A summary of the ITT data from the IMpower133 study that support this approval is included below:1

Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54–0.91, p=0.0069) in the ITT population.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (median PFS=5.2 versus 4.3 months; HR=0.77; 95% CI: 0.62–0.96, p=0.017).
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
Grade 3–4 treatment-related adverse events occurred in 56.6% of people receiving Tecentriq plus chemotherapy, compared with 56.1% of people receiving chemotherapy alone. The most common adverse reactions (≥10%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).
About SCLC
Lung cancer is the leading cause of cancer death globally.5 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.5 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.2

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

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. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On February 14, 2020 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported that it will participate in two upcoming conferences (Press release, IDEXX Laboratories, FEB 14, 2020, View Source [SID1234554367]):

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Monday, February 24, 10:55 am EST – Brian McKeon, Executive Vice President and Chief Financial Officer, and Tina Hunt, PhD, Executive Vice President, Point of Care Diagnostics and Worldwide Operations, will present at the Bank of America Merrill Lynch Animal Health Summit, New York, New York.
Monday, March 2, 10:25 am EST – Jay Mazelsky, President and Chief Executive Officer, will present at the 41st Annual Raymond James Institutional Investors Conference, Orlando, Florida.
Individuals can access the live audio webcasts of the presentations through links on the IDEXX website, View Source An archived edition of the presentations will be available via the same link