logo
Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹ Français

Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹ Français

Cision Canada6 days ago
KIRKLAND, QC, July 21, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada has granted approval for KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. 1,2 The approval is based on data from the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, which demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients randomized to KEYTRUDA ® in combination with CRT compared with patients randomized to placebo plus CRT. 3
"The approval of KN-A18 is an important addition to the treatment of gynecological cancers, as it has demonstrated a statistically significant improvement in overall survival and progression-free survival in patients with FIGO 2014 Stage III-IVa," stated Shannon Salvador, Gynecologic Oncologist at the Jewish General Hospital and President of the Society of Gynecologic Oncology of Canada. 4"This recent approval adds another therapeutic option for patients in an important disease space."
"This approval marks a pivotal moment for patients, as it represents the first indication in Canada for KEYTRUDA ® in combination with chemoradiotherapy," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "Reaffirming our commitment to cervical cancer, we are eager to continue expanding treatment options for patients impacted by this disease." 5
About KEYNOTE-A18 / ENGOT-cx11/GOG-3047
KEYNOTE-A18 is a multicenter, randomized, double-blind, placebo-controlled phase III trial (ClinicalTrials.gov, NCT04221945). 2 The trial investigated the efficacy of pembrolizumab in combination with CRT (cisplatin and external beam radiation therapy [EBRT] followed by brachytherapy [BT]) for the treatment of patients with locally advanced cervical cancer. 1
The trial enrolled 1,060 newly diagnosed patients with locally advanced squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix defined as FIGO 2014 stage IB2 to IIB with positive lymph nodes or stage III to IVA regardless of nodal status. 3 There were 599 patients with FIGO 2014 Stage III-IVA.
Randomization was stratified by planned type of EBRT (Intensity modulated radiation therapy [IMRT] or volumetric modulated arc therapy [VMAT] vs. non IMRT and non VMAT), stage at screening of cervical cancer (FIGO 2014 Stage IB2 IIB vs. FIGO 2014 Stage III-IVA), and planned total radiotherapy dose (EBRT + brachytherapy dose of <70 Gy vs. ≥70 Gy as per equivalent dose [EQD2]). 1
Patients were randomized (1:1) to one of two treatment arms:
Pembrolizumab 200 mg IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by pembrolizumab 400 mg IV every 6 weeks (15 cycles). 1,3
Placebo IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice), and radiotherapy (EBRT followed by BT), followed by placebo IV every 6 weeks (15 cycles). 1,3
Treatment continued until RECIST (Response Evaluation Criteria in Solid Tumors) v1.1-defined progression of disease as determined by investigator or unacceptable toxicity. 1
Assessment of tumour status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year 3, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or histopathologic confirmation, and OS. 1
The trial demonstrated statistically significant improvements in both PFS (HR (Hazard Ratio) 0.70; 95% CI (confidence interval): 0.55–0.89; p = 0.002) and OS (HR 0.67; 95% CI: 0.50–0.90; p = 0.004) in the overall population. In an exploratory subgroup analysis for the 459 patients (43%) with FIGO 2014 Stage IB2–IIB disease, the PFS and OS HR estimates were 0.91 (95% CI: 0.63–1.32) and 0.89 (95% CI: 0.55–1.44), respectively, suggesting that the improvements in PFS and OS observed in the overall population were primarily driven by the later-stage subgroup of patients with FIGO 2014 Stage III–IVA disease.
The efficacy results in the exploratory subgroup analysis of 599 patients with FIGO 2014 Stage III-IVA disease showed that pembrolizumab plus CRT demonstrated improvements in PFS (Hazard Ratio (HR) 0.59; 95% CI 0.43, 0.81) and OS (HR 0.58; 95% CI 0.40, 0.85) in the overall population. 1
For the FIGO 2014 Stage III-IVA population, the most common treatment-related adverse events (reported in at least 20% of patients) were anemia, nausea, diarrhea, white blood cell count decreased, neutrophil count decreased, vomiting, platelet count decreased, and hypothyroidism. 6
For complete information, refer to the KEYTRUDA ® product monograph.
About cervical cancer
Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. 7 Despite concerted efforts in screening and prevention across Canada, cervical cancer has become the fastest growing cancer type in females. 8,9 In 2024 alone, it was estimated that there were approximately 1,600 women diagnosed with cervical cancer and an estimated 400 deaths as a result of the disease. 10
About KEYTRUDA ®
KEYTRUDA ® is an anti-programmed death receptor-1 (anti-PD-1) therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA ® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 11,12,13
KEYTRUDA ® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. 14
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
® Merck Sharp & Dohme LLC. Used under license.
© 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
CA-NON-04142
1 KEYTRUDA ® Product Monograph, page 285-286.
2 https://clinicaltrials.gov/study/NCT04221945
3 The ASCO Post. KEYNOTE-A18: Overall Survival in Cervical Cancer Improved by Pembrolizumab Plus Chemoradiotherapy. https://ascopost.com/issues/october-10-2024/keynote-a18-overall-survival-in-cervical-cancer-improved-by-pembrolizumab-plus-chemoradiotherapy/
4 Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial, page 1329.
5 https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1426
6 KEYTRUDA ® Product Monograph, page 146.
7 Canadian Cancer Society. What is cervical cancer?
8 Canadian Cancer Statistics 2023, page 22. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2023-statistics/2023_pdf_en.pdf?rev=7e0c86ef787d425081008ed22377754d&hash=DBD6818195657364D831AF0641C4B45C
9 Canadian Cancer Statistics 2023, page 80. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2023-statistics/2023_pdf_en.pdf?rev=7e0c86ef787d425081008ed22377754d&hash=DBD6818195657364D831AF0641C4B45C
10 Canadian Cancer Society. Cervical cancer statistics. https://cancer.ca/en/cancer-information/cancer-types/cervical/statistics
11 KEYTRUDA ® Product Monograph, page 300.
12 KEYTRUDA ® Product Monograph, page 188.
13 KEYTRUDA ® Product Monograph, page 192.
14 KEYTRUDA ® Product Monograph, pages 1-3.
Media Contacts:
Merck Canada Media Relations
1-833-906-3725
[email protected]
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

JBO Thailand Launches Esports World Cup Promotion with Rewards Up to 30,000 Jcoin
JBO Thailand Launches Esports World Cup Promotion with Rewards Up to 30,000 Jcoin

Cision Canada

time3 hours ago

  • Cision Canada

JBO Thailand Launches Esports World Cup Promotion with Rewards Up to 30,000 Jcoin

BANGKOK, July 27, 2025 /CNW/ -- JBO, a well-established online gaming and entertainment platform, is pleased to announce an exciting new promotion tailored for the highly anticipated Esports World Cup 2025. Esports enthusiasts in Thailand now have a compelling opportunity to win up to 30,000 Jcoin by placing wagers on the thrilling "World Cup Qualifiers" matches. This shows JBO Thailand's commitment to giving great value and fun experiences to all its players. This exclusive event is ongoing and will conclude on August 24, 2025, at 23:59 (GMT+8). This period strategically aligns with the intensified global esports calendar, leading up to the Esports World Cup and its critical qualifying rounds. JBO Thailand is actively creating an immersive environment that allows fans to engage more deeply with preferred teams and competitive events. Participation in the promotion is straightforward. Players are simply required to place bets on eligible "Esports World Cup Qualifiers" matches through JBO's designated esports betting providers, IM Esports and TF Esports. The promotion is conveniently accessible via the "Reward Corner" section on the JBO platform, ensuring a seamless and intuitive user experience for all participants. At the core of this attractive offer is JBO's innovative Jcoin reward system. Players who log in to JBO and achieve a weekly turnover exceeding 3,000 in the Esports category will automatically qualify for Jcoin rewards. The reward system gives bigger prizes as you play more, with up to 30,000 Jcoin available each week. JBO also ensures a smooth and secure experience through the easy-to-use JBO app available for both Android and iOS devices. With fast withdrawals and smooth gameplay, the platform is ideal for esports fans to enjoy and earn real rewards. JBO is trusted across Asia and has Dimitar Berbatov as its brand ambassador, showing it as a top sportsbook and esports operator. JBO or Just Bet Online, is a trusted online gaming website that started in 2019 catering Thailand users. Players can bet on popular games like DOTA 2, CS:GO, and ROV, or enjoy fun slot machines and real-time casino tables. It also hosts fun events such as the JBO Thailand Super Cup engaging football fans.

Better Quantum Computing Stock: IonQ vs. Rigetti Computing
Better Quantum Computing Stock: IonQ vs. Rigetti Computing

Globe and Mail

time6 hours ago

  • Globe and Mail

Better Quantum Computing Stock: IonQ vs. Rigetti Computing

Key Points IonQ and Rigetti Computing have developed fundamentally different methods to create quantum computers. IonQ aspires to build the internet of the future while Rigetti focuses on commercializing its superconducting qubit technology. Neither IonQ nor Rigetti are profitable, although they have amassed large sums of cash to fund their operations. 10 stocks we like better than IonQ › The quantum computing industry is a promising area to invest in. Quantum machines can complete complex calculations in minutes that would take classical computers centuries, thanks to the power of quantum mechanics. In the sector, IonQ (NYSE: IONQ) and Rigetti Computing (NASDAQ: RGTI) are among the prominent players. IonQ uses ions to power its quantum machines while Rigetti employs the traditional superconducting qubits process. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » Both have seen impressive share price increases over the past year. IonQ stock is up over 400% through July 23 while Rigetti climbed more than 1,000% in that time. Is one a better investment in the nascent quantum computing field? Examining these businesses in more detail can help to arrive at an answer. Rigetti Computing's tried-and-true tech Rigetti uses a proven method of producing qubits. Qubits are a quantum device's equivalent to a classical computer's bit. But while bits represent a zero or one, the properties of quantum mechanics mean qubits can be both at the same time, enabling orders of magnitude faster processing speeds. Superconducting qubits offer several advantages. They can be manufactured using existing semiconductor chip processes, and can complete calculations faster than ion-based quantum machines. Rigetti hopes to gain greater commercialization with the latest version of its quantum computer, the Ankaa-3 system, which launched at the end of 2024. However, the technology isn't cheap. Superconducting qubits require special cryogenic equipment to keep temperatures colder than outer space. This is necessary for qubits to maintain stability long enough to perform calculations before they break down. As a result, the company exited the first quarter with an operating loss of $21.6 million on sales of $1.5 million. The loss is 30% greater than the previous year while Q1 revenue plunged 52% year over year. This combination of falling revenue and rising costs is unsustainable over the long run. That's why Rigetti executed a $350 million equity offering that helped it build up a stockpile of $575 million in cash, cash equivalents, and investments with no debt as of June 11. This cash hoard should sustain the company's operations in the short term, but it will need to produce revenue growth to build a sustainable business. IonQ's lofty ambition to remake the internet IonQ's ion-based method holds several advantages over superconducting qubits. Its tech can operate at room temperature, eschewing the need for cryogenic equipment. The technology also offers low error correction rates. Because qubits quickly break down, quantum computers are prone to calculation mistakes that limit their ability to scale. IonQ's reduced error rates make scalability a possibility. Consequently, the company aims to construct a quantum computing network, reminiscent of the infrastructure that underpins today's world wide web. It pursued several acquisitions to achieve its goal of building "the next generation of the internet," in the words of IonQ Chairman Peter Chapman. But like Rigetti, IonQ's costs are rising. It posted a Q1 operating loss of $75.7 million, an increase from 2024's $52.9 million, on revenue of $7.6 million. So it, too, is pursuing an equity offering to the tune of $1 billion. In addition, IonQ believes it can hit revenue of $75 million to $95 million in 2025. This would be a strong increase over 2024, when sales soared 95% year over year to $43.1 million. Making the choice between IonQ and Rigetti Computing stock Although Rigetti's superconducting qubits technology is well established in the quantum computing industry, IonQ's approach is producing higher sales. On top of that, another factor to consider is share price valuation. This can be assessed using the price-to-sales (P/S) ratio, a metric commonly used when companies are not profitable. Data by YCharts. The chart reveals Rigetti's P/S multiple has skyrocketed from where it was a year ago, and is far higher than IonQ's as well. This suggests Rigetti stock is overpriced, making IonQ the better value. That said, IonQ stock is not cheap, given it has a P/S ratio exceeding 200. While quantum computers hold the promise of revolutionizing the computing industry, whether IonQ or Rigetti's approach will win out in the end is far from certain. After all, quantum computing is still in its infancy. Its market size was just $4 billion in 2024, although industry estimates predict rapid growth to $72 billion by 2035. As of now, IonQ's 2024 sales success coupled with an outlook of 2025 revenue growth, and a far better valuation compared to Rigetti, make its stock the superior quantum computing investment between these two businesses. Ideally, wait for a dip in IonQ's share price, and for its Q2 results to validate it's on a trajectory to hit 2025 sales targets before deciding to pick up shares. Should you invest $1,000 in IonQ right now? Before you buy stock in IonQ, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and IonQ wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $636,628!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,063,471!* Now, it's worth noting Stock Advisor's total average return is 1,041% — a market-crushing outperformance compared to 183% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 21, 2025

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store