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Clarity to present at ASCO and SNMMI 2023 Annual Meetings

On May 26, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that new data will be presented at the upcoming ASCO (Free ASCO Whitepaper) and SNMMI 2023 Annual Meetings, covering clinical and pre-clinical results in multiple oncology indications (Press release, Clarity Pharmaceuticals, MAY 26, 2023, View Source [SID1234632138]). The data showcases the breadth of Clarity’s TCT platform of developing multiple products to treat a multitude of cancers with high unmet medical needs.

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings are the most prestigious conferences in oncology and nuclear medicine, respectively. We are delighted that our data has been accepted for presentation at these major forums. The abstracts accepted for presentation highlight the exciting possibilities of our next-generation TCT radiopharmaceuticals, addressing some of the challenges of the current-generation of radiopharmaceutical products and expanding the platform into multiple malignancies. We look forward to further developing our existing as well as novel TCT products as we get closer to our ultimate goal of improving treatment outcomes for children and adults with cancer."

Data to be presented at 2023 ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings

Product

Abstract Title`

Authors

Conference

64Cu SAR-bisPSMA
64Cu-SAR-bisPSMA (PROPELLER) Positron Emission Tomography (PET) Imaging in Patients With Confirmed Prostate Cancer
Eva Lengyelova, Veronica Wong, Nat Lenzo, Michelle Parker, Louise Emmett

2023 ASCO (Free ASCO Whitepaper) Annual Meeting

Session title: Genitourinary Cancer — Prostate, Testicular, and Penile
Session date: 3rd June
Session time: 8am-11am
Poster Board: 133
Abstract number: 5039

64Cu SAR-bisPSMA
Comparison of PET/CT in Subjects with Confirmed Prostate Cancer Using 64Cu SAR-bisPSMA and 68Ga PSMA-11
Eva Lengyelova, Veronica Wong, Nat Lenzo, Michelle Parker, Louise Emmett

2023 SNMMI Annual Meeting

64Cu/67Cu SAR-bisRGD
Cu-64/Cu-67 SAR-bisRGD as a theranostic for cancer

Ellen van Dam, Lachlan McInnes, Benjamin Blyth, Jessica Van Zuylekom, Buck E. Rogers, Cristian Wieczorek Villas Boas, Yi Rao, Jason S. Lewis, Kurt Gehlsen, Jeff Norenberg, Matt Harris

2023 SNMMI Annual Meeting

64Cu SAR-5B1 and SAR-5B1 and 64Cu SAR-bisRGD
Copper-67 based targeted radiotherapy primes immunologically cold pancreatic adenocarcinoma for immunotherapy

Yi Rao, Tara Viray, Ellen Van Dam, Kurt Gehlsen, Matt Harris, Lachlan Mclnnes, Jeff Norenberg, Jason S Lewis

2023 SNMMI Annual Meeting

Poster abstracts will be available on Clarity’s official website after their presentation at the 2023 ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings: claritypharmaceuticals.com/pipeline/scientific_presentations

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

On May 26, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1% (Press release, Bristol-Myers Squibb, MAY 26, 2023, View Source [SID1234632137]). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

"The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease," said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. "Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to reduce the risk of disease recurrence, progression and death in resectable NSCLC when given before surgery. The CHMP’s recommendation moves us another step closer to addressing the pressing need to offer certain patients in the European Union a chance to change the course of their disease with an effective and tolerable pre-surgical option that may help reduce the risk of relapse."

The positive opinion is based on results from the CheckMate -816 trial, which demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) with three cycles of Opdivo in combination with chemotherapy compared to chemotherapy alone when given before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC. Primary analyses of pCR, EFS and preliminary overall survival (OS) data from CheckMate -816 were previously presented at medical congresses and published in the New England Journal of Medicine. Three-year data demonstrating durable clinical benefits with the combination were presented at the European Lung Cancer Congress 2023. CheckMate -816 is ongoing to assess key secondary endpoints and subgroup analyses, including OS, which continue to mature.

To date, Opdivo with chemotherapy has been approved for the neoadjuvant treatment of patients with resectable NSCLC regardless of PD-L1 expression levels in 21 countries, including the United States, Japan and China, and additional regulatory applications are under review by global health authorities. Opdivo-based treatments have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -816 clinical trial.

About CheckMate -816

CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo with chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable stage IB to IIIA non-small cell lung cancer (per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control staging criteria). For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three cycles, or platinum doublet chemotherapy every three weeks for three cycles, followed by surgery. The primary endpoints of the trial are event-free survival and pathologic complete response, regardless of PD-L1 expression. Secondary endpoints include overall survival, major pathologic response, and time to death or distant metastases.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

Aurealis Therapeutics Accelerates Oncology Program: First abstract published at ASCO as the team prepares for Annual Meeting in Chicago

On May 26, 2023 Aurealis Therapeutics, a synthetic biology company developing ground-breaking cell and gene therapies for unmet medical needs, reported its expansion in Oncology with its first-in-class four-in-one Bacterial Cell and Gene Therapy AUP-55 (Press release, Aurealis Therapeutics, MAY 26, 2023, View Source [SID1234632136]). The company’s first abstract, Effect of multi-targeting bacterial gene therapy on tumor regression and survival in mouse models of ovarian and intraperitoneal cancer, has been accepted and published on the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website.

This moment marks a pivotal turning point for Aurealis Therapeutics, as the company expands from its acclaimed focus on chronic wounds into the field of oncology and creates therapeutic solutions such as AUP-55 for ovarian, intraperitoneal or bladder cancer. The Aurealis Therapeutics Team is proud for the publication of its first abstract as it prepares for its participation in the ASCO (Free ASCO Whitepaper) Annual Meeting which will take place from 2-6 June in Chicago, IL.

AMGEN TO PRESENT AT THE TD COWEN 4TH ANNUAL ONCOLOGY INNOVATION SUMMIT

On May 26, 2023 Amgen (NASDAQ: AMGN) reported that it will present at the TD Cowen 4th Annual Oncology Innovation Summit at 11:00 a.m. ET on Wednesday, May 31, 2023. David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference (Press release, Amgen, MAY 26, 2023, View Source [SID1234632134]). The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

PharmaMar announces the abstracts that will be presented at the ASCO 2023 congress

On May 26, 2023 PharmaMar (MSE:PHM) has reported that it will present, together with its partners, seven new abstracts from various clinical studies with Zepzelca (lurbinectedin) and Yondelis (trabectedin) at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)), which will be held from June 2 to 6, 2023 virtually and in person in Chicago, United States (Press release, PharmaMar, MAY 26, 2023, View Source [SID1234632088]).

Among the studies that will be presented during the congress, two oral presentations with two PharmaMar compounds stand out. With the abstract titled: " Efficacy of combination lurbinectedin (LURBI) + doxorubicin (DOX) from the phase 1B soft-tissue sarcoma (STS) lead-in to a randomized phase 2 trial in leiomyosarcoma (LMS)", Dr. Gregory Cote , a medical oncologist at Massachusetts General Hospital, will present updated efficacy and tolerability data of the combination of lurbinectedin with doxorubicin, from the phase 1B introduction of soft tissue sarcoma to a phase II randomized trial in leiomyosarcoma (LMS).

For his part, Dr. Peter Reichardt, Chief Medical Officer of the HELIOS Klinikum Berlin-Buch Interdisciplinary Oncology Clinic, will present the abstract entitled: "Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc)", in which he will present data on the efficacy and safety of trabectedin plus nivolumab as second-line treatment of patients with metastatic or inoperable soft tissue sarcoma previously treated with anthracyclines. The study confirms the activity of trabectedin plus nivolumab, particularly in patients with lipo or leiomyosarcomas, suggesting a synergistic activity. Furthermore, the safety of trabectedin and nivolumab was consistent with the safety profiles of each drug separately, with no new findings relevant to the combination.

All ASCO (Free ASCO Whitepaper) abstracts are available upon request to registered participants for 180 days from May 26, 2023: View Source

Studies featured at ASCO (Free ASCO Whitepaper) 2023

PRODUCT TITLE PRIMARY AUTHOR ABSTRACT
Zepzelca (lurbinectedina) Efficacy of combination lurbinectedin (LURBI) + doxorubicin (DOX) from the phase 1B soft-tissue sarcoma (STS) lead-in to a randomized phase 2 trial in leiomyosarcoma (LMS) Gregory Cote ABSTRACT: 11507 SESSION TYPE: Oral Abstract Session S100a DATE: June 5, 2023 11:30 – 14:30 GMT-5
Zepzelca (lurbinectedina) Efficacy and safety of lurbinectedin in elderly patients with relapsed SCLC Sophie Cousin ABSTRACT: 8591 SESSION TYPE: Poster Session POSTER: 218 DATE: June 4, 2023 8:00 – 11:00 GMT-5
Zepzelca (lurbinectedina) A phase III study of lurbinectedin alone or in combination with irinotecan vs investigator’s choice (topotecan or irinotecan) in patients with relapsed small cell lung cancer (SCLC; LAGOON trial) Benjamin Besse ABSTRACT: TPS8613 SESSION TYPE: Poster Session POSTER: 233a DATE: June 4, 2023 8:00 – 11:00 GMT-5
Zepzelca (lurbinectedina) IFCT-2105 lurbiclin real-world effectiveness and treatment sequences in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) who received lurbinectedin as part of the French Early Access Program (EAP-ATU) Nicolas Girard ABSTRACT: 8584 SESSION TYPE: Poster Session POSTER: 211 DATE: June 4, 2023 8:00 – 11:00 GMT-5
Yondelis (trabectedin) Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) Peter Reichardt ABSTRACT: 11500 SESSION TYPE: Oral Abstract Session S100a DATE: June 5, 2023 11:30 – 14:30 GMT-5
Yondelis (trabectedin) SARC037: Results of phase I study of trabectedin given as a 1-hour (h) infusion in combination with low dose irinotecan in relapsed/refractory Ewing sarcoma (ES) Patrick Grohar ABSTRACT: 11519 SESSION TYPE: Poster Discussion Session POSTER: 453 DATE: June 3, 2023 16:30 – 18:00 GMT-5
Yondelis (trabectedin) Trabectedin (T) versus adriamycin plus dacarbazine (A-DA) in advanced solitary fibrous tumor (SFT): Results from a phase II randomised clinical study (STRADA) Silvia Stacchiotti ABSTRACT: 11571 SESSION TYPE: Poster Session POSTER: 505 DATE: June, 2023 13:15 – 16:15 GMT-5