On October 17, 2025 Novartis reported results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The five-year invasive disease-free survival (iDFS) rates were 85.5% in the Kisqali plus ET arm versus 81.0% in the ET alone arm, representing a clinically meaningful 4.5% improvement1. These late-breaking results will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

"For the thousands of people diagnosed with early breast cancer each year, the fear of recurrence, often as incurable advanced disease, weighs heavily on patients and their families," said Dr. John Crown, Consultant Medical Oncologist at St. Vincent’s University Hospital, Dublin, and NATALEE investigator. "These five-year results show that the benefit of ribociclib persists well beyond the completion of treatment, offering these at-risk patients a greater chance of living breast cancer-free."

As follow-up continued, the confidence intervals (CIs) became narrower1. This pattern held across clinically relevant subgroups, reinforcing the robustness of the observed iDFS benefit1.

"These data reinforce the potential of Kisqali to significantly reduce the long-term risk of breast cancer recurrence, extending well beyond the three-year treatment period. This provides physicians and patients with greater confidence in long-term disease management. Kisqali is redefining the standard of care in adjuvant therapy, including in patients with node-negative disease," said Dushen Chetty, Global Head of Oncology and Hematology Development at Novartis, Ad Interim. "The consistency of the benefit observed across both advanced and early breast cancer settings, together with Kisqali’s established safety profile, underscores its position as the CDK4/6 inhibitor with the most comprehensive Phase III evidence base for improving patient outcomes."

Overall survival (OS) continues to show an encouraging trend, with further improvement in the hazard ratio (HR) to 0.800 and narrowing CI (95% CI: 0.637-1.003; one-sided nominal p-value 0.026) compared to the final iDFS analysis (OS HR = 0.892 (0.661-1.203)), demonstrating a 20% reduction in the risk of death compared to ET alone1. The NATALEE trial will continue follow-up to ensure sufficient data is collected for OS and other long-term endpoints.

iDFS results across pre-specified subgroups1:

Subgroups Hazard ratio 95% CI Absolute risk reduction at 5 years
Overall population 0.716 0.618-0.829 4.5%
Stage II 0.660 0.493-0.884 3.7%
Stage III 0.730 0.615-0.865 5.6%
Node-negative (N0) 0.606 0.372-0.986 5.7%
Node-positive (N1-3) 0.737 0.631-0.860 4.4%
With a median of around two years after all patients completed Kisqali treatment, long-term safety shows no new safety signals1. Overall, rates of secondary primary malignancies (SPMs) were 2.7% (Kisqali plus ET) and 3.0% (ET alone), while SPMs leading to deaths were reported in one patient in each group1.

Kisqali remains the only CDK4/6 inhibitor to demonstrate statistically significant OS benefits across three randomized controlled trials in advanced breast cancer (MONALEESA-2, MONALEESA-3, and MONALEESA-7)2-12.

*OS data remain immature at the five-year NATALEE analysis

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an adjuvant treatment versus ET alone in the broadest range of patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO13,14. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable13,14. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria13,14. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial13,14.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, helping slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, enable cancer cells to grow and divide quickly. Targeting CDK4/6 with enhanced precision plays a role in tumor control.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in more than 100 countries worldwide, including the U.S. FDA and the European Commission15,16. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET15. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression16. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist15,16.

In EBC, Kisqali is the only CDK4/6 inhibitor recommended by the NCCN Guidelines for breast cancer as Category 1 preferred for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 317. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration18. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials2-12. The NCCN Guidelines also recommend Kisqali as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC17.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC19; and has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of four out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer20. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line21.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656736])

On October 17, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation & immunology (I&I), reported the first disclosure of interim data from the ongoing Phase 2 trial of its lead program, invikafusp alfa, during a late-breaking oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Meeting, taking place October 17-21, 2025, in Berlin, Germany.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These highly anticipated results continue to validate Marengo’s first-in-class precision T cell activation platform – a novel approach aimed at fully addressing the significant unmet need for both PD-1 resistant and refractory patients, as well as those for whom PD-1 therapy is not currently indicated.

"The compelling single-agent activity and tumor regression we’re observing across multiple tumor types, particularly in PD-1-resistant tumors, underscore the potential of invikafusp alfa as a new pan-tumor backbone immunotherapy," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "By selectively activating Vβ6/Vβ10 T-cell subsets, we are unlocking distinct immune biology that can reprogram the tumor microenvironment and reinvigorate anti-tumor T cell responses in patient populations who have exhausted current immunotherapies."

As of the July 29, 2025 data cutoff, 55 patients with advanced solid tumors harboring high mutational burden (TMB-H or MSI-H/dMMR) were enrolled across 21 histologies; 44 were efficacy-evaluable. Additional outcomes from the Phase 2 study are outlined below.

Tumor shrinkage: 52% of patients experienced target-lesion regression.
In the TMB-H patients, there was a 20.5% overall response rate (ORR) (9/44) and a 79.5% disease control rate (DCR) (35/44) across six tumor types, including colorectal, gastric, lung, breast, GEJ, and head and neck cancers.
In the MSI-H/dMMR patients, there was a 30% ORR (3/10) and 70% DCR (7/10).
Clinical efficacy was observed in PD-1-resistant/refractory tumors and PD-1 naive tumors where PD-1 was not approved as standard of care, confirming PD-1-independent activity.
The safety profile was consistent with selective T cell activation mechanism of action, and treatment-related AEs were transient and manageable with supportive care.
Building on these clinical data, Marengo is advancing a post-PD-1, biomarker-enriched strategy for invikafusp alfa – continuing the Phase 2 monotherapy expansion in TMB-H or MSI-H/dMMR solid tumors to further characterize the depth and durability of responses across priority indications. In parallel, Marengo is pursuing ongoing regulatory interactions, including recently securing U.S. FDA Fast Track designation in TMB-H mCRC.

To reach broader, frontline populations beyond biomarker TMB-H in large indications, the company is also progressing a Phase 2 combination with Trodelvy (TROP2-directed ADC) in TNBC and HR+/HER2– breast cancer to evaluate synergy in ADC and IO settings.

Invikafusp alfa is a first-in-class, bispecific dual T-cell agonist designed to selectively activate and expand Vβ6/Vβ10 T-cell subsets, which represent ~10% of tumor-infiltrating lymphocytes (TILs). Marengo’s lead asset was designed to restore and amplify anti-tumor immunity in patients who have progressed on or are insensitive to prior immune checkpoint blockade, and it has demonstrated rapid progress to date. Phase 1/2 results of the STARt-001 clinical trial evaluating invikafusp alfa in antigen-rich solid tumors were first presented at SITC (Free SITC Whitepaper) 2024, followed by disclosure of the recommended Phase 2 dose (RP2D) selection rationale and early clinical activity at AACR (Free AACR Whitepaper) 2025.

(Press release, Marengo Therapeutics, OCT 17, 2025, View Source;resistant-solid-tumors-as-a-late-breaking-oral-presentation-at-esmo-2025-302587142.html [SID1234656753])

On October 16, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported the pricing of an underwritten offering to a select group of institutional investors consisting of 21,895,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase an aggregate of up to 28,713,500 shares of its common stock. Each share of common stock and each pre-funded warrant is accompanied by a Class A Warrant and a Class B Warrant, each to purchase one share of common stock (or pre-funded warrant in lieu thereof) at an exercise price of $2.22 per share.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering was led by RA Capital Management with participation from existing shareholders including OrbiMed, Soleus Capital, Lynx1 Capital Management, and Bain Capital Life Sciences.

The Class A Warrants are exercisable at any time through the earlier of (i) 30 days after the achievement of a trigger tied to the clinical results from the planned Phase 1b trial of cemsidomide with elranatamab, or (ii) five years from the date of issuance. The Class B Warrants are exercisable at any time prior to the fifth anniversary of the date of issuance and, under certain circumstances based on stock appreciation, C4T may require the mandatory exercise of the warrants. The shares of common stock (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.47 per share of common stock and accompanying warrants, and the pre-funded warrants (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.4699 per pre-funded warrant and accompanying warrants, which represents the per share price of the common stock less the $0.0001 per share exercise price for each pre-funded warrant.

All securities in the offering are being sold by C4T. The aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses and excluding any proceeds from potential exercise of the Class A and Class B Warrants and nominal proceeds from potential exercise of the pre-funded warrants, are expected to be $125.0 million. If all Class A and Class B Warrants and pre-funded warrants are exercised, the aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $349.7 million. The offering is expected to close on or about October 17, 2025, subject to the satisfaction of customary closing conditions.

Together with its existing cash and cash equivalents and marketable securities, C4T intends to use the net proceeds of the offering to primarily fund its ongoing and planned clinical trials of cemsidomide, other research and development activities, and for working capital and general corporate purposes.

Jefferies, TD Cowen and Evercore ISI are acting as book-running managers for the offering.

The securities were offered by C4T pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on October 31, 2024 and declared effective by the SEC on November 13, 2024 (File No. 333-282933). The prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering will be made only by means of the prospectus supplement and the accompanying prospectus.

(Press release, C4 Therapeutics, OCT 16, 2025, View Source [SID1234656697])

On October 16, 2025 Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class therapies targeting escape mutations in hematologic malignancies and solid tumors, reported the presentation of preclinical data for its novel, brain-permeable CDK2 inhibitor at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The compound demonstrates high selectivity for CDK2 over other cyclin-dependent kinases (CDKs), excellent safety and tolerability, and a broad therapeutic window in models of multiple cyclin-E1 (CCNE1)–CDK2–dependent neoplasms that exhibit poor response to current standard-of-care treatments, including approved CDK4/6 and investigational CDK2 inhibitors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Eilean plans to present the drug candidate data at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) and to advance this highly selective CDK2 inhibitor into a First-in-Human clinical study in Q4 2025.

"Targeting CCNE1/CDK2-driven cancers remains an urgent unmet medical need," said Nikolay Savchuk, PhD, Chief Operating Officer at Eilean Therapeutics. "Our data demonstrate that this compound achieves an optimal balance of potency, selectivity, and brain permeability, supporting its potential to benefit patients with aggressive, therapy-resistant solid tumors."

(Press release, Eilean Therapeutics, OCT 16, 2025, View Source [SID1234656715])

On October 16, 2025 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported to host a R&D Day in New York City. The Company’s leadership team and key opinion leaders will present the full Phase 1 dataset and outline the pivotal Phase 2 trial design and commercial opportunity for lasme-cel in r/r B-ALL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the Event:

Date: Today, October 16, 2025
Time: 08:30 – 10:30 a.m. ET
Format: In-person and live webcast
Webcast: Join live via View Source

A replay will be available after the event on the Cellectis website.

(Press release, Cellectis, OCT 16, 2025, View Source [SID1234656698])