On February 26, 2021 Incyte (Nasdaq:INCY) reported the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy (Press release, Incyte, FEB 26, 2021, View Source [SID1234575694]). The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

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"The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

"While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

The MAA is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy which were presented at the 2020 virtual ESMO (Free ESMO Whitepaper) Congress.

SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 In Europe, each year approximately 12,000 patients receive SCAC diagnosis.2 Patients with metastatic SCAC have a poor 5-year survival and there are no approved treatments for patients who progress on platinum therapy.3

About POD1UM-202

POD1UM-202 (NCT03597295) is a global, open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

For more information about the study, please visit View Source

About POD1UM

The POD1UM (PD1 Inhibitor Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 in SCAC along with and benchmarking studies in endometrial cancer, Merkel cell carcinoma and other solid tumors. A Phase 3 trial in NSCLC (POD1UM-304) is also enrolling, as are studies in combination with epacadostat, pemigatinib, and other development compounds in the Incyte portfolio.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell anal carcinoma (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer, and the Biologics License Application for retifanlimab has been accepted for Priority Review.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

On February 26, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Tuesday, March 2, 2021 at 8:30 AM ET to discuss results for the fourth quarter and year-end 2020 and provide a business outlook for 2021 (Press release, TG Therapeutics, FEB 26, 2021, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-fourth-quarter-and-year-0 [SID1234575737]). Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Fourth Quarter and Year End 2020 Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On February 26, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021, at 12:20 p.m. ET (Press release, Supernus, FEB 26, 2021, https://ir.supernus.com/news-releases/news-release-details/supernus-present-cowen-healthcare-conference [SID1234575763]).

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A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay will be available for 60 days on the Company’s website following the conference.

On February 26, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that management will be holding one-on-one meetings with investors during the Virtual 33rd Annual Roth Conference, being held March 15 – 17, 2021 (Press release, Celsion, FEB 26, 2021, View Source [SID1234575779]). A webcast of Celsion’s presentation will be pre-recorded and will be available on the Company’s website during the week before the conference.

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Institutional and other investors interested in meeting with Celsion during the conference should contact their Roth Capital Partners sales representative or LHA Investor Relations. Conference information is available at www.roth.com/oc2021virtual.

On February 26, 2021 Sanofi reported The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy (Press release, Sanofi, FEB 26, 2021, View Source [SID1234575764]).

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"Sarclisa has demonstrated superior results in combination with two standard of care regimens, reinforcing its potential to become the anti-CD38 of choice for the treatment of multiple myeloma," said Peter Adamson, Global Development Head, Oncology and Pediatric Innovation at Sanofi. "We look forward to partnering with the European Commission to make Sarclisa available to more patients and are committed to investigating Sarclisa in combination with current standard of care treatments throughout all lines of multiple myeloma therapy."

Sarclisa is currently approved for use in the European Union (EU) in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

The use of Sarclisa in combination with carfilzomib and dexamethasone is not currently approved in the EU, but the final decision whether to expand the indication is expected from the European Commission in the coming months.

Sarclisa Phase 3 study results in patients with MM

The CHMP positive opinion is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM.

Secondary endpoints of the IKEMA trial assessed the depth of response for Sarclisa combination therapy compared to Kd, including overall response rate (ORR), complete response (CR), very good partial response (VGPR) and minimal residual disease (MRD)-negative response. There was no statistically significant difference in ORR, which remained similar for each arm at 86.6% for the Sarclisa combination therapy versus 82.9% for Kd (p=0.1930). The rate of CR was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm. The rate of VGPR was 72.6% for patients receiving Sarclisa combination therapy and 56.1% for patients receiving Kd. MRD-negative complete response was observed in 29.6% of patients in the Sarclisa combination therapy arm versus 13% of patients in the Kd arm, indicating that nearly 30% of patients treated with Sarclisa combination therapy achieved undetectable levels of MM at 10-5 sensitivity as measured by next generation sequencing (NGS). At the time of the interim analysis, overall survival (OS) data were still immature.

The most frequent adverse reactions (≥20%) were infusion reactions (45.8%), hypertension (36.7%), diarrhea (36.2%), upper respiratory tract infection (36.2%), pneumonia (28.8%), fatigue (28.2%), dyspnea (27.7%), insomnia (23.7%), bronchitis (22.6%), and back pain (22.0%). Serious adverse reactions occurred in 59.3% of patients receiving Sarclisa combination therapy and versus 57.4% in patients receiving Kd. The most frequent serious adverse reaction was pneumonia (21.5%). Permanent discontinuation of treatment because of adverse reactions was reported in 8.5% of patients treated with Sarclisa combination therapy and in 13.9% of patients treated with Kd. Fatal adverse events were reported in 3.4% of patients treated with Sarclisa combination therapy and in 1.6% of patients treated with Kd.

Multiple Myeloma: An incurable cancer, despite available treatments

Multiple myeloma is the second most common hematologic malignancy1, with more than 130,000 new diagnoses of multiple myeloma worldwide yearly.2 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year.3 Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. Relapsed multiple myeloma is the term for when the cancer returns after treatment or a period of remission. Refractory multiple myeloma refers to when the cancer does not respond or no longer responds to therapy.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the EU, U.S., Switzerland, Canada, Australia, Japan, Russia, the UAE, South Korea and Taiwan in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.