KEYTRUDA® (pembrolizumab) Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of Overall Survival (OS) Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer

On February 27, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible. These data will be presented for the first time today during a Best Oral Session at the European Society of Gynaecological Oncology (ESGO) 2026 Congress (abstract #526).

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As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, KEYTRUDA plus paclitaxel with or without bevacizumab met its primary endpoint of progression-free survival (PFS) in the all comers population of patients with platinum-resistant recurrent ovarian cancer, as well as in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The KEYTRUDA regimen also met its key secondary endpoint of OS in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1).

At the final analysis, after a median follow-up of 32.7 months (range, 26.1-44.1), KEYTRUDA plus paclitaxel with or without bevacizumab demonstrated a statistically significant and clinically meaningful improvement in OS in all comers, reducing the risk of death by 18% (HR=0.82 [95% CI, 0.69-0.97]; p=0.0115) compared to paclitaxel with or without bevacizumab alone. For patients who received the KEYTRUDA regimen, median OS was 17.7 months versus 14.0 months for patients receiving the placebo regimen. The observed OS is among the longest reported in any clinical trial for platinum-resistant recurrent ovarian cancer, showing a clinically meaningful benefit of this regimen relative to the most active standard of care control arm, weekly paclitaxel with bevacizumab in bevacizumab-eligible patients.

"Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer."

Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1), and who have received one or two prior systemic treatment regimens.

In February, KEYTRUDA plus paclitaxel with or without bevacizumab was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens based on previous data from the KEYNOTE-B96 trial.

"Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers."

Study design and additional data from KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

At the final analysis, in the all comers population, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of disease progression or death by 27% (HR=0.73 [95% CI, 0.62-0.87]) compared to paclitaxel with or without bevacizumab alone. In patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), the KEYTRUDA regimen reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.62-0.93]) versus paclitaxel with or without bevacizumab alone. The KEYTRUDA regimen also continued to demonstrate a clinically meaningful improvement in OS, a key secondary endpoint of the study, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.62-0.93]) compared to paclitaxel with or without bevacizumab.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety concerns were identified. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 67.8% of patients receiving the KEYTRUDA regimen (n=320) versus 55.3% of patients receiving the placebo regimen (n=318). TRAEs led to death in 1.3% of patients receiving the KEYTRUDA regimen and 1.6% of patients receiving the placebo regimen.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.4% of patients receiving the KEYTRUDA regimen and 18.9% of patients receiving the placebo regimen. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (18.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs led to death in 0.6% of patients in the KEYTRUDA arm and in no patients in the placebo arm.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, FEB 27, 2026, View Source [SID1234663125])

MonTa Biosciences Initiates Expansion Phase with Systemic TLR7 Agonist MBS8 in Checkpoint-Resistant Melanoma Amid Renewed Momentum in the TLR7 Field

On February 27, 2026 MonTa Biosciences, a Copenhagen-based clinical-stage biotech company developing next-generation innate immune modulators for cancer therapy, reported the expansion of its clinical program with MBS8, a systemically administered second-generation TLR7 agonist, in checkpoint-resistant cutaneous melanoma and metastatic uveal melanoma.

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Unlike first-generation systemic TLR7 approaches that were limited by toxicity, MBS8 utilizes a proprietary lipid micelle formulation designed to enable controlled innate immune activation while maintaining systemic tolerability. Phase I evaluation established a favorable safety profile, encouraging tumor effects and a recommended dose for further development

The multi-center expansion study will enroll patients in Denmark and Spain. MBS8 will be evaluated in combination with pembrolizumab (Keytruda) in patients with acquired resistance to PD-1 therapy, and as monotherapy in uveal melanoma patients previously treated with T-cell engagers.

CEO Statement
"We are very encouraged by the MBS8 phase I data generated and believe systemic TLR7 agonism is entering a new era of clinical validation and investment momentum," said Simon Skjøde Jensen, CEO of MonTa Biosciences. "With Phase I safety established, we are advancing MBS8, which we believe has Best-in-class potential, into defined resistant melanoma populations where innate immune activation may restore responsiveness to immunotherapy. As capital and clinical momentum accelerate in the TLR7 field, we see a clear opportunity to differentiate through safety, formulation, and rational combination strategies."

Addressing Checkpoint Resistance
Although immune checkpoint inhibitors have transformed melanoma treatment, up to 40–50% of responding patients ultimately relapse—representing approximately 10-12,000 patients annually across the US and EU—with no broadly effective therapy specifically targeting acquired resistance.

Orphan Opportunity in Metastatic Uveal Melanoma
Metastatic uveal melanoma remains a major unmet need, with approximately 4,000 new cases annually in the US and Europe. The indication qualifies for orphan designation, offering potential regulatory incentives and accelerated development pathways. Checkpoint inhibitors show response rates below 10%, and while a T-cell engager is approved for a subset of patients, durable responses remain limited.

TLR7 Agonism Gains Clinical Validation and Reduces Development Risk
Systemic TLR7 agonism is rapidly re-emerging as a validated immuno-oncology strategy, supported by substantial capital deployment and advancing clinical data. Eikon Therapeutics has raised more than USD 1 billion to advance its TLR7 agonist EIK1001 into Phase II/III development and completed its NASDAQ listing in February 2026. Interim Phase II data in NSCLC demonstrated improved progression-free survival when EIK1001 was combined with chemotherapy and pembrolizumab, reinforcing the clinical relevance of systemic innate immune activation.

In parallel, a landmark Nature publication (Grippin et al., 2025) showed that NSCLC and melanoma patients receiving an mRNA COVID-19 vaccine—known to partly activate TLR7 signaling—within 100 days of initiating checkpoint therapy experienced significantly improved survival, including nearly doubled 36-month overall survival in NSCLC.
Collectively, these developments materially reduce development and clinical risk for MBS8 and underscore its potential to enhance checkpoint efficacy.

MonTa’s MBS8 is, alongside EIK1001, among the most advanced systemically administered TLR7 agonists with completed Phase I safety data, positioning the company at the forefront of this revalidated therapeutic class.

(Press release, MonTa Biosciences, FEB 27, 2026, View Source [SID1234663126])

Nkarta to Participate in March Investor Conferences

On February 27, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported its participation in the following investor conferences:

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March 2, 2026
TD Cowen 46th Annual Health Care Conference
Boston, MA
9:10 a.m. EST – fireside chat

March 10, 2026
Leerink Global Healthcare Conference
Miami, FL
10:40 a.m. EDT – fireside chat

A simultaneous webcast of both events will be available on the Investors section of Nkarta’s website, and a replay will be archived on the website for approximately 90 days.

(Press release, Nkarta, FEB 27, 2026, View Source [SID1234663128])

Defence Therapeutics Announces Private Placement Of Units For Proceeds Of Up To $11 Million

On February 27, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the launch of a private placement (the "Private Placement") of up to 20,000,000 units (the "Units") at a price of $0.55 per Unit, for aggregate gross proceeds to Defence of up to $11,000,000. Each Unit will be comprised of one common share (each, a "Share") and one common share purchase warrant ("Warrants"). Each Warrant will entitle its holder to acquire an additional common share of the Company at a price of $0.65 per share for 24 months following the date of issuance.

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The Company has executed a binding term sheet with two arm’s length institutional investors (collectively, the "Investors") in connection with the Private Placement for aggregate gross proceeds of $6,000,000 (CAD) (the "Investors’ Proceeds"). In connection with the Private Placement, the Investors’ Proceeds and the Units will be deposited in escrow in advance of closing pursuant to an escrow agreement (the "Escrow Agreement"). Upon closing, the Units will be released from escrow and delivered to the Investors or as they may direct, and the Investors’ Proceeds will be released from escrow and deposited as credit support pursuant to an ISDA Credit Support Annex, and released to the Company in monthly cash tranches of $333,333 (CAD) over an 18-month period (the "Term"), pursuant to the terms and conditions of a sharing agreement (the "Sharing Agreement") to be dated and executed on the closing of the Private Placement. Settlements under the Sharing Agreement shall commence five months after closing.

Pursuant to the Sharing Agreement, Shares will be released in equal monthly installments of approximately 606,060 Shares over the 18-month Term, with each release contingent upon the corresponding cash payment being delivered to the Company. The Sharing Agreement shall provide that the Company’s economic interest will be determined in 18 monthly settlement tranches as measured against a benchmark price of $0.7332 (CAD) per Share (the "Benchmark Price"). If, at the time of settlement, the settlement price (determined monthly based on a 20-day volume-weighted average trading price of the Company’s shares on the CSE) exceeds the Benchmark Price, the Company shall receive more than 100% of the monthly settlement due, on a pro rata basis, with no upper limit on additional proceeds. If the settlement price is below the Benchmark Price, the Company will receive less than 100% of the monthly settlement due, on a pro rata basis. In no event will a decline in the settlement price result in an increase in the number of Shares being issued to the Investors. As a result, the Company may ultimately receive more or materially less than the original proceeds of $6,000,000. The final amount received will depend on the Company’s future share price, which is subject to market fluctuations and may vary over time. Accordingly, there is no assurance as to the total amount the Company will receive under the Sharing Agreement.

All 10,909,091 Warrants to be issued shall be exercisable at an exercise price of $0.65 (CAD) per Share for a period of 24 months following the date of issuance. The Warrants will include an equity blocker provision that prohibits the holder from exercising any portion of the Warrants if such exercise would result in the holder owning more than 9.99% of the Company’s outstanding Shares.

The Investors will receive a corporate finance fee of $360,000 (CAD) in connection with the Sharing Agreement, payable in cash or via the issuance of 654,546 Units at the Private Placement price, at the election of the Company (the "Fee").

The Company has agreed to pay a non-refundable deposit of $65,000 (CAD)
(the "Deposit") upon receipt of approval from the CSE in connection with the Private Placement. The Deposit shall be satisfied by the issuance of 118,182 Units at the Private Placement price.

Defence intends to use the proceeds from the Private Placement to advance its Antibody Drug Conjugate ("ADC") and Radiopharmaceutical programs, to develop partnerships and for working capital purposes. The Company may pay a finder’s fee in connection with the offering to eligible arm’s-length finders in accordance with the policies of the Canadian Securities Exchanges.

Pursuant to applicable Canadian securities laws and in accordance with the Exchange policies, all securities issued under this Private Placement will be subject to applicable resale restrictions under applicable securities laws. The closing of the Private Placement is expected on or about March 6, 2026, subject to the approval of the CSE.

The Units described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions there from. This press release does not constitute an offer to sell or a solicitation to buy any securities in any jurisdiction.

(Press release, Defence Therapeutics, FEB 27, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-private-placement-of-units-for-proceeds-of-up-to-11-million [SID1234663221])

Novartis successfully completes acquisition of Avidity Biosciences, strengthening late-stage neuroscience pipeline and advancing xRNA strategy

On February 27, 2026 Novartis AG (NYSE: NVS) reported that it has successfully completed its acquisition of Avidity Biosciences, Inc. ("Avidity"). With the completion of the acquisition, Avidity is now an indirect, wholly owned subsidiary of Novartis.

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"Avidity’s breakthrough science combined with Novartis capabilities will help reimagine what’s possible for people with devastating genetic neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "Avidity’s muscle-directed AOC platform and late-stage programs advance our RNA therapeutics and have the potential to deliver first-in-disease therapies. With the close of the acquisition, we’re excited to welcome Avidity to Novartis and accelerate this next generation of medicines."

Novartis completed the acquisition of Avidity through the merger of its indirect wholly owned subsidiary, Ajax Acquisition Sub, Inc., with and into Avidity. As a result of the merger, holders of Avidity common stock became entitled to receive USD 72.00 per share in cash, valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn. Avidity’s shares of common stock have also ceased trading on the Nasdaq Stock Market LLC. The transaction was originally announced on Oct. 26, 2025.

(Press release, Novartis, FEB 27, 2026, View Source [SID1234663129])