On December 3, 2020 McKesson Corporation reported the launch of Ontada, an oncology technology and insights business designed to support innovation, acceleration, and evidence generation to drive better outcomes for patients with cancer (Press release, McKesson, DEC 3, 2020, View Source [SID1234572141]).

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"Ontada reflects McKesson’s continued commitment and investment in the oncology community," said Brian Tyler, chief executive officer, McKesson. "As one of the largest healthcare companies, McKesson is at the center of care delivery, which provides a unique perspective on the complexities of cancer care and the growing needs among providers and life sciences companies. With the launch of Ontada, we can now build upon our differentiated assets in oncology and deliver innovative solutions that help improve patient outcomes."

Building on McKesson’s long history in community oncology, Ontada combines its real-world data and research capabilities with a leading suite of technologies for oncology clinicians – including the iKnowMed℠ electronic health record system and Clear Value Plus℠ regimen support tool – as well as a connection to a national community oncology network to transform the fight against cancer.

Ontada is uniquely positioned to advance cancer care by enabling deep collaboration between life sciences companies and oncology providers. Its team of data scientists and oncology experts help life sciences companies leverage evidence-based data and insights to accelerate innovation and improve cancer therapy, while empowering providers to deliver the best care and improved outcomes for patients. Ontada will provide a number of real clinical benefits to enable life sciences companies to help bring breakthrough oncology products to market sooner and better support the entire patient journey.

Through its deep connections to oncology practices, Ontada can help expand the reach of therapies with engagement and education opportunities with physicians. The benefits that Ontada can offer to providers are further enhanced through its strong relationship with McKesson’s The US Oncology Network, as well as other community oncology practices.

"At The US Oncology Network, we collaborate with practices to leverage evidence-driven care to deliver better patient outcomes," said Michael Seiden, M.D., Ph.D., president, The US Oncology Network. "We’re thrilled to have Ontada as a technology partner who shares our vision and will provide us with the tools and insights we need to put patients first."

On December 3, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, DEC 3, 2020, View Source [SID1234572140]). The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.1 The Company has also established an expanded access program (EAP) [NCT04599712]2 for patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit View Source

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Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.3,4,5,6 In March 2020, amivantamab received Breakthrough Therapy Designation from the FDA for this population.7

"This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs."

The BLA submission for amivantamab is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib*, a novel third-generation EGFR tyrosine kinase inhibitor (TKI)8, in adult patients with advanced NSCLC.9 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1** (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.8,10 Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Abstract #9512).10

"Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at Johnson & Johnson are committed to improving outcomes for patients diagnosed with this complex, deadly disease. With today’s submission for amivantamab, we are one step closer to that goal," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "We are steadfast in our focus to advance novel therapeutics and medicines that will transform the trajectory of some of the most challenging and deadly diseases of our time, including lung cancer."

EGFR mutations, leading to uncontrolled cancer cell growth and division11, are some of the most common mutations in NSCLC.12 EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.13 However, EGFR exon 20 insertion mutations are also often undetected.13 Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertion mutations and broader use of NGS can help to detect these mutations.14 Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and, in addition, carries a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.15 Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months16, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months.17

*In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

**RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same, or get bigger.

About Amivantamab

Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.3,4,5,6 Amivantamab is pending regulatory review as a potential treatment for patients with NSCLC with EGFR exon 20 insertion mutations whose tumors typically do not respond to current standard of care. Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.

About the Amivantamab Expanded Access Program Protocol (EAP)

The amivantamab EAP is for U.S. patients 18 years of age or older who have histologically or cytologically confirmed unresectable or metastatic NSCLC with an EGFR exon 20 insertion mutations who are not amenable to curative therapy and whose disease has progressed during or after current standard of care platinum-based chemotherapy, who may benefit from treatment with amivantamab prior to its potential FDA approval.2 The EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program, and patients must not be eligible for another amivantamab study.2 Interested patients should contact their physician to discuss whether they may be a candidate for amivantamab through the EAP.2 Additional information about the expanded access protocol can be found on clinicaltrials.gov (NCT04599712) and at View Source

About Non-Small Cell Lung Cancer (NSCLC)

Worldwide, lung cancer is the most common cancer, and NSCLC makes up 80 to 85 percent of all lung cancers.18,19 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.19 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.11 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.20 The five-year survival rate for all patients with metastatic NSCLC with EGFR mutations treated with EGFR TKIs is less than 20 percent.21,22 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.11

On December 3, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announced that the Board, at its meeting reported the appointment of Hedi Ben Brahim as the Company’s new Chairman and CEO, effective January 1st, 2021 (Press release, Transgene, DEC 3, 2020, View Source(Paris%3ATNG)%2C,effective%20January%201st%2C%202021. [SID1234572139]). Hedi Ben Brahim, who has been a member of Transgene’s Board since May 2019, will replace Philippe Archinard. Philippe Archinard has led the company since 2005 and will remain a member of the Board of Transgene.

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Alain Mérieux, honorary Chairman of Transgene, said: I would like to thank Philippe Archinard for his commitment to Transgene over the last 15 years. Under his leadership, the Company has demonstrated the potential of virus-based immunotherapies and developed world class innovative therapies that could be game-changers in the field of cancer treatment. Based on these achievements, I believe Transgene is now ideally placed to further demonstrate the value of its approaches. I am confident that Hedi Ben Brahim, together with Transgene’s highly skilled team, will build on this strong foundation to generate multiple novel virus-based immunotherapeutics that will both deliver important clinical benefits to cancer patients and value for shareholders."

"It is a great honor and pleasure to join the Transgene executive team. I am excited to take on this new role having seen the significant potential of Transgene’s technology platforms and their potential to bring improved clinical benefits to cancer patients globally. Trangene’s Invir.IO and myvac platforms are significant breakthroughs in multi-armed oncolytic virus therapy and individualized vaccines respectively. In addition, with the positive Phase 1b/2 data of TG4001, Transgene has established the relevance of its virus-based immunotherapy for HPV-positive cancer patients. I look forward to continuing the development of this promising candidate and further strengthen our exciting immune-oncology pipeline", added Hedi Ben Brahim.

Hedi Ben Brahim joins Transgene from Institut Mérieux where he was Vice-President for Immunotherapy since September 2018. In this role, he was the Chairman of ABL Inc., a contract research & development, and contract biomanufacturing organization (CRO/CMO). Prior to joining the Institut Mérieux, he was General Manager at a subsidiary of Vallourec, a solutions provider to the energy sector. Hedi began his career in the public sector at the Ministry of the Economy, Action and Public Accounts, then at the Ministry of Social Affairs and Health. He is a graduate of the École Polytechnique and the École Nationale Supérieure des Mines de Paris.

Philippe Archinard will become Executive Vice-President, Technological Innovation and Scientific Partnerships at Institut Mérieux. Philippe Archinard will remain Board Member of Transgene.

Transgene’s Board has also been notified of the change of the Director representing TSGH (Institut Mérieux); Dominique Takizawa is to be replaced by Sandrine Flory as of January 1st, 2021. Sandrine has been Chief Financial Officer of Institut Mérieux since March 2020. She has spent 18 years at bioMérieux, in various positions in finance. She was CFO for bioMérieux EMEA from 2014 to 2020. Prior to joining bioMérieux, Sandrine spent 9 years at PriceWaterhouseCoopers in France and Australia. Sandrine holds a master in Finance and Accounting and a MS in Business Valuation and Transmission from the Université Lyon 2 (France).

On December 3, 2020 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit on Thursday, December 10, 2020 at 11:45 A.M. EST (Press release, Kintara Therapeutics, DEC 3, 2020, View Source [SID1234572138]).

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Dr. John de Groot, Professor, Department of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry, Professor of Neurology, at the University of Toronto Temerty Sunnybrook Research Institute will present a talk titled "Kintara’s VAL-083: A First-in-Class Bifunctional Alkylating Agent with Promising Activity in MGMT Promoter- Unmethylated & Methylated Glioblastoma."

Drs. de Groot and Perry are the Principal Investigators of Kintara’s arm of the Global Coalition for Adaptive Research (GCAR) Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study.

ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH

GCAR is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors.

On December 3, 2020 UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported the presentation of final data from the UGN-101 Jelmyto (mitomycin) for pyelocalyceal solution Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC) (Press release, UroGen Pharma, DEC 3, 2020, View Source [SID1234572137]). The results will be presented as a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology (SUO):

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Oral Session: Best of Bladder Cancer
Abstract #: 1003
Title: Durability of Response to Chemoablative Treatment of Low-Grade Upper Tract Urothelial Carcinoma with a Mitomycin-Containing Reverse Thermal Hydrogel: Final Results of the OLYMPUS Trial
Presenter: Surena F. Matin, M.D., Professor of Urology at The University of Texas MD Anderson Cancer Center in Houston, TX
Session Date & Time: Saturday, December 5, 2020; 2:00 pm Eastern Time
Final results from the Phase 3 OLYMPUS trial of Jelmyto, the first and only non-surgical kidney-sparing treatment approved by the U.S. Food and Drug Administration (FDA) for adults with LG-UTUC, show that Jelmyto demonstrated clinically meaningful response in adults with LG-UTUC. In both the OLYMPUS intent-to-treat population and in the sub-population of patients who were deemed to have unresectable disease at study entry, 58% of patients achieved a complete response (CR) with durability of response at 12-months estimated to be 81.8% by Kaplan-Meier analysis. Median time to recurrence was not reached.

"Current options for patients with low-grade upper tract urothelial carcinoma are not optimal. They include multiple endoscopic procedures or the removal of the kidney and ureter, both of which have consequences impacting patient health and quality of life," said Surena F. Matin, M.D., Professor of Urology at The University of Texas MD Anderson Cancer Center in Houston, TX and Investigator of the OLYMPUS trial. "The results of the OLYMPUS study represent the first prospective trial in this space, supporting the use of Jelmyto as a less-invasive, kidney-preserving, durable treatment for low-grade upper tract urothelial carcinoma, which may reduce the need for multiple endoscopic procedures or loss of a kidney."

The safety profile in the final OLYMPUS data was consistent with previously reported results. The most common adverse events (AE) were uretic stenosis, urinary tract infection, hematuria, flank pain, nausea, dysuria, renal dysfunction, abdominal pain and vomiting.

About the Phase 3 OLYMPUS Trial

OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of UGN-101, Jelmyto (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade UTUC. Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of Jelmyto administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine Complete Response (CR), the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer and for cause biopsy. Patients who achieved a CR at the PDE timepoint were continued onto the maintenance phase of the trial, during which they were to receive monthly maintenance instillations for up to 12 months to determine the durability of response with Jelmyto.

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda/gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.