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G1 Therapeutics’ COSELA® (trilaciclib) Recommended in Updated Small Cell Lung Cancer Guidelines from the American Society of Clinical Oncology (ASCO)

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.

G1 Therapeutics to Release Third Quarter 2023 Financial Results and Provide Business Update on November 1, 2023

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]).

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.

Exelixis to Release Third Quarter 2023 Financial Results on Wednesday, November 1, 2023

On October 18, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2023 financial results will be released on Wednesday, November 1, 2023 after the markets close (Press release, Exelixis, OCT 18, 2023, View Source [SID1234636105]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.

CytomX Therapeutics Presents Preclinical Profile of EpCAM-directed Antibody Drug Conjugate CX-2051 at 2023 World ADC Conference

On October 18, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that the Company presented data characterizing the preclinical profile of its EpCAM-targeting ADC, CX-2051, at the World ADC conference taking place October 16-19, 2023, in San Diego, CA (Press release, CytomX Therapeutics, OCT 18, 2023, View Source [SID1234636104]).

"CX-2051 is designed to address the unmet needs of patients with EpCAM-expressing tumors, including colorectal cancer, where EpCAM expression is uniformly high. EpCAM is a broadly expressed, validated anti-cancer target that to date has been limited in its development potential due to systemic, on-target off-tumor dose-limiting toxicities", said Marcia P. Belvin, Ph.D., senior vice president and chief scientific officer at CytomX.

Continued Dr. Belvin, "Based on our experience with the Probody Platform and our clinical experience with Probody-ADCs, we have designed CX-2051 to mask target binding in normal tissues and include a next-generation topoisomerase-1 inhibitor payload. We are encouraged by the compelling preclinical profile of CX-2051 and anticipate filing an IND for the program by the end of the year. We aim to launch Phase 1 dose escalation for CX-2051 in solid tumors in 2024, with an initial focus in metastatic colorectal cancer as a priority indication."

Details for the presentation are as follows:
Presentation Title: Leveraging Conditional Activation to Localize Antibody Drug Conjugates to the Tumor
"Clinical Lessons" Track
Session Date and Time: October 18, 2023, 12:30 pm PST

The full presentation is available at the following link:

Leveraging Conditional Activation to Localize Antibody Drug Conjugates to the Tumor
Marcia P. Belvin, Ph.D., Senior Vice President, Chief Scientific Officer, CytomX Therapeutics

Checkpoint Therapeutics Announces Publication of Cosibelimab Pivotal Trial Results in the Journal for ImmunoTherapy of Cancer

On October 18, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma ("cSCC"), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Checkpoint Therapeutics, OCT 18, 2023, View Source [SID1234636103]). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma" (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.

Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity. The study’s primary endpoint was objective response rate ("ORR") assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1. As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results. Median duration of response was not yet reached. The authors observed that cosibelimab treatment was associated with lower rates of severe immune-related adverse events ("irAEs") as compared with those reported for similar studies of PD-1-targeting agents, concluding that cosibelimab may address an area of unmet clinical need for effective and better tolerated treatments for patients with metastatic cSCC who are ineligible for curative surgery or radiation.

"The conclusions of the study are clear," commented Prof. Philip Clingan of Southern Medical Day Care Centre in Wollongong, Australia, Principal Investigator for this study and first author of the paper. "Cosibelimab is the first PD-L1-blocking antibody to demonstrate a robust and clinically meaningful ORR, with durable responses in participants, and a well-tolerated safety profile in patients with metastatic cSCC. While existing PD-1-blocking antibodies are approved to treat advanced cSCC, many patients don’t respond to treatment, experience severe irAEs or are simply not appropriate candidates for PD-1 therapy treatment, such as those that are immunocompromised, immunosuppressed or with preexisting autoimmune disease. There is therefore a significant need for improved therapies. Cosibelimab, if approved, would offer patients an important new treatment option through its dual activation of both innate and adaptive immunity to induce strong and durable anti-tumor responses, complemented by lower rates of severe adverse events as cosibelimab’s binding to PD-L1 leaves the interaction of PD-1 and PD-L2 unaltered."

"Publication of these data expands the growing evidence supporting the efficacy and safety of cosibelimab," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time. We believe cosibelimab’s dual mechanism of action and potential favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients upon its potential launch early next year. We continue to work with the U.S. Food and Drug Administration ("FDA") toward the January 3, 2024, action date for our Biologics License Application for cosibelimab."

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab
Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.