On October 18, 2023 Prescient Therapeutics (ASX:PTX) reported that its abstract for the results of a Phase 1b study in T-cell lymphomas has been accepted for poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December (Press release, RAPT Therapeutics, OCT 18, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-two-flx475-presentations-society [SID1234636112]).

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The meeting is the largest and most comprehensive hematology conference in the world.

Prescient Therapeutics managing director and CEO, Steven Yatomi-Clarke, said, "It is a huge honour to have our abstract presented at the world’s most prestigious haematology conference. This is a validation of the quality and relevance of the clinical data we are generating in T-cell lymphomas, which is an area of unmet clinical need. It is also a testament to the hard work by the Prescient team and our clinical collaborators.

"Prescient looks forward to presenting this data at ASH (Free ASH Whitepaper) and will release this data to the market concurrently."

On October 18, 2023 PharmaMar (MSE:PHM) reported that it will present new data on lurbinectedin in Small Cell Lung Cancer (SCLC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, being held in Madrid from October 20-24th (Press release, PharmaMar, OCT 18, 2023, View Source [SID1234636111]).

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Among the most outstanding studies will be an oral presentation by Dr. Antonio Calles, where final data from the LUPER trial of lurbinectedin in combination with pembrolizumab (immunotherapy) in second-line SCLC will be presented. The presentation called "Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER study" concludes that the combination of lurbinectedin and pembrolizumab is an effective second-line treatment for SCLC in patients who did not receive prior immunotherapy, achieving in some cases deep and durable responses, with a manageable safety profile and no new emerging signs of toxicity when combining the two drugs.

Dr. Antonio Calles, Specialist in Medical Oncology at the Hospital General Universitario Gregorio Marañón, Madrid, Spain, who has led the study, comments "the combination represents an opportunity for those patients with metastatic SCLC, who could not be treated with first-line immunotherapy. The treatment achieved a confirmed response rate of 46.4%, including deep and durable responses that exceeded one year in some patients. Median Progression-Free Survival (PFS) was significantly longer for platinum-sensitive patients compared to platinum-resistant patients, with a PFS of 10 versus3 months, respectively. Currently, the only treatment other than lurbinectedin approved for this indication in the last 2 decades, has a response rate of only ~20% and a PFS of 4 months, in addition to very significant toxicity. However, here we saw no unexpected side effects both drugs could be safely combined at full doses".

Dr. Ali Zeaiter, Vice President and Head of Clinical Development at PharmaMar said: "We are pleased to present new data on the combination of lurbinectedin with immunotherapy. We believe that these data, with the suggested improvements in patients’ outcomes, confirm once again that lurbinectedin is an important treatment option for relapsed SCLC and support the ongoing investigation of lurbinectedin combination with immunotherapy".

In addition to the above presentation, the study entitled "A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study" will show the final Overall Survival (OS) data for the combination of doxorubicin and trabectedin of 33.1 months versus 23.8 months for doxorubicin alone. These data confirm that this is the first drug combination that is able to demonstrate benefit in both PFS and OS in a phase III trial in first-line treatment of metastatic leiomyosarcoma. These data have supported further the rationale of also studying lurbinectedin in sarcoma.

Lead investigator, Dr. Patricia Pautier, from the Institut Gustave Roussy in Villejuif, Paris, France, comments "the final results were positive with a median progression-free survival (PFS) statistically improved from 6.2 months with doxorubicin alone to 12.2 months with the combination."

PharmaMar’s abstracts at ESMO (Free ESMO Whitepaper) 2023

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER study Dr. Antonio Calles Mini oral presentation ABSTRACT: 1989MO DATE: Saturday, October 21st, 14:50 – 14:55 CET
Lurbinectedin (LRB) pharmacokinetics (PK) and safety when co-administered with itraconazole (ITZ) in patients with advanced solid tumor Dra. Irene Moreno ABSTRACT: 679P DATE: Monday, October 23rd
Supportive measures to control myelosuppression and costs for patients with SCLC with lurbinectedin, CAV or topotecan with or without trilaciclib: a review on the basis of clinical trials Dr. Manuel Domine ABSTRACT: 2024P DATE: Saturday, October 21st
Yondelis (trabectedin) A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study Patricia Pautier Proffered Paper presentation ABSTRACT: #2965 DATE: Sunday, October 22nd, 08:30-10:00 CET
TOMAS2: a randomized phase 2 study from the Italian Sarcoma Group (ISG) of trabectedin plus olaparib (T+O) or trabectedin (T) in advanced, metastatic, or unresectable soft tissue sarcomas (STS) after failure of standard treatments. Lorenzo D’Ambrosio Proffered Paper presentation ABSTRACT: #4076 DATE: Sunday, October 22nd, 08:30-10:00 CET.
Tolerability and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in elderly patients with ovarian cancer (OC) – GEICO 105-O Study María Jesús Rubio ABSTRACT: 770P DATE: Sunday, October 22nd
Trabectedin plus radiotherapy on symptomatic advanced sarcoma patients, results from the SYNERGIAS study: a Spanish group for research in sarcoma (GEIS) phase II study Javier Martin Broto ABSTRACT: 1926P DATE: Monday, October 23rd
Targeting Microenvironment and Cellular Immunity in Sarcomas with Trabectedin Combined With Metronomic Cyclophosphamide: The TARMIC study Cheng-Ming Su ABSTRACT: 1924P DATE: Monday, October 23rd

On October 18, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, reported that the first patient in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in advanced ovarian cancer has begun treatment (Press release, IMUNON, OCT 18, 2023, View Source [SID1234636108]). IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer (the OVATION 2 Study).

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This Phase 1/2 trial is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL) and the secondary endpoint is progression-free survival (PFS). Initial SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

The principal investigator of this clinical trial is Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will also be involved in translational analyses using trial samples and animal models of ovarian cancer MRD, including biomarker and genomic analyses, which is expected to expand the Company’s knowledge of the treatment paradigm. These initiatives are a part of the Break Through Cancer Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using Immune and DNA Repair Directed Therapies TeamLab collaboration.

Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, "This new trial testing the combination of IMNN-001 and bevacizumab in ovarian cancer starts as we have just announced very encouraging interim data for our OVATION 2 program evaluating the benefits of IMNN-001 in the neoadjuvant setting. We believe the combination of IMNN-001 and bevacizumab holds promise based on findings in our earlier pre-clinical animal studies, where the combination showed strong synergies. IMNN-001 as an innovative immunotherapy may transform the current ovarian cancer first line treatment landscape and provide new options to women diagnosed with Stage III/IV disease who face low cure rates of 15% or less."

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced Stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stages III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 (formerly GEN-1) is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The Company previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. It announced full enrollment in the OVATION 2 Study in September 2022, interim data in September 2023 and expects to report topline data in the second quarter of 2024.

On October 18, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that COSELA (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) small cell lung cancer (SCLC) guidelines for patients with untreated or previously treated extensive-stage small cell lung cancer (ES-SCLC) who are undergoing treatment with chemotherapy or chemoimmunotherapy (Press release, G1 Therapeutics, OCT 18, 2023, View Source [SID1234636107]). COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

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"The inclusion of COSELA in these new ASCO (Free ASCO Whitepaper) SCLC guidelines is essential, as they inform treatment decisions by U.S. physicians caring for people living with small cell lung cancer," said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics. "The mounting body of evidence from our clinical trials and real-world studies demonstrates the potential of COSELA to protect the bone marrow of patients with ES-SCLC against the harmful effects of chemotherapy. These updated guidelines provide further clarity and confidence to physicians considering cytotoxic therapies for their patients with untreated and previously treated SCLC."

Published on October 11, 2023, the SCLC guidelines, entitled "Systemic Therapy for SCLC: ASCO (Free ASCO Whitepaper)-Ontario Health (Cancer Care Ontario) Guideline" (Khurshid et al.) provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. ASCO (Free ASCO Whitepaper)’s clinical practice guidelines outline appropriate methods of treatment and care for clinicians and address specific clinical situations (disease-oriented) or the use of approved medical products, procedures, or tests (modality-oriented). Multidisciplinary panels of experts, including patient advocates, develop ASCO (Free ASCO Whitepaper)’s clinical practice guidelines. For more information on ASCO (Free ASCO Whitepaper)’s guidelines in thoracic cancer, including the SCLC guidelines, please follow this link.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication

COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On October 18, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a financial and corporate update for the third quarter 2023 on Wednesday November 1, 2023, at 8:30 a.m. ET (Press release, G1 Therapeutics, OCT 18, 2023, View Source [SID1234636106]).

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Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.