Keytruda » Pharmtales

FDA Approves Keytruda for Biliary Cancer, Rivals AstraZeneca’s Imfinzi

2 November 2023 by Anika Sharma

Keytruda Wins FDA Nod for Biliary Cancer

Merck’s Keytruda has received FDA approval to treat locally advanced unresectable or metastatic biliary tract cancer, alongside gemcitabine and cisplatin chemotherapy, marking its entry into this challenging cancer space. This approval signifies Keytruda’s sixth FDA nod for gastrointestinal cancer treatment. The FDA’s decision was based on data from Merck’s Phase 3 KEYNOTE-966 trial, demonstrating that … Read more

Keytruda: Merck’s breakthrough cancer drug with mixed results at ESMO

24 October 2023 by Anika Sharma

Keytruda: Merck’s cancer drug shines and falters at ESMO

Merck & Co. made significant strides at this year’s European Society for Medical Oncology (ESMO) congress, presenting a series of groundbreaking studies highlighting Keytruda’s efficacy across multiple cancer types. However, there was one notable setback. Keytruda, Merck’s PD-1 inhibitor, demonstrated complete and partial victories in cervical cancer, early breast cancer, and stomach cancer across four … Read more

Padcev-Keytruda Combo Doubles Survival in First-Line Bladder Cancer Trial (ESMO 2023)

23 October 2023 by Anika Sharma

Padcev-Keytruda Beats Chemo in Bladder Cancer (ESMO 2023)

ESMO 2023: LBA6 Exciting results from the EV-302 phase 3 trial suggest that the partnership between Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s renowned oncology treatment Keytruda may be a harmonious breakthrough in the field of bladder cancer. Several weeks ago, the medical community buzzed with anticipation when Seagen and Astellas revealed the improved … Read more

Opdivo Beats Chemo in First-Line Bladder Cancer, But Keytruda-Padcev Combo Looms Large (ESMO 2023)

23 October 2023 by Anika Sharma

Opdivo vs Chemo vs Keytruda-Padcev in Bladder Cancer (ESMO 2023)

ESMO 2023: LBA7 Bladder cancer has presented a unique challenge for immunotherapies, with Bristol Myers Squibb’s Opdivo making strides, but its success has been somewhat overshadowed by competing data. The addition of Opdivo to cisplatin-based chemotherapy has shown a promising reduction in the risk of death for previously untreated bladder cancer, a notable 22% decrease. … Read more

Lilly Unveils Exciting Phase III Showdown: Retevmo vs. Keytruda & Chemotherapy in RET Fusion-Positive NSCLC

22 October 2023 by Anika Sharma

Retevmo Beats Keytruda + Chemo in RET+ NSCLC

ESMO 2023: LBA4 RET fusion is found in about 1-2% of patients with non-small cell lung cancer. Retevmo, a highly selective and potent RET inhibitor that effectively crosses the blood-brain barrier, has received approval for treating advanced RET fusion-positive NSCLC. Currently, two selective RET inhibitors, Gavreto (pralsetinib) and Retevmo (selpercatinib), have obtained FDA approval. Outcomes … Read more

KEYNOTE-671 Trial: Keytruda Sets New Standards in the Perioperative Treatment Landscape (ESMO 2023)

22 October 2023 by Anika Sharma

Keytruda + Chemo Boosts Survival in Resectable NSCLC (ESMO 2023)

ESMO 2023: LBA56 Neoadjuvant NSCLC is a challenging market with few treatment options and many unmet needs. Merck’s Keytruda is widely recognized as the best treatment for 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status. In October 2023, the FDA approved Merck’s Keytruda before and after surgery, along with chemotherapy, to help … Read more

Keytruda’s Success in KEYNOTE-756 Trial Ushers in a New Era for Early-Stage High-Risk ER+/HER2– Breast Cancer Treatment (ESMO 2023)

22 October 2023 by Anika Sharma

ESMO 2023: Keytruda + Chemo Boosts pCR in ER+/HER2– Breast Cancer

ESMO 2023: LBA21 Keytruda (pembrolizumab) is a highly specific, human-made antibody that targets the PD-1 pathway and prevents cancer cells from escaping the immune system. It has been approved for treating early-stage TNBC with high risk of recurrence. In a Phase III study by Merck, KEYNOTE-756, a major breakthrough was achieved: a remarkable increase in … Read more

How Keytruda Improved Survival Outcomes for Early-Stage TNBC Patients: KEYNOTE-522 Trial

22 October 2023 by Anika Sharma

Conference, ESMO 2023, Keytruda, Breast Cancer, LBA18, KEYNOTE-522

ESMO 2023: LBA18 Underpinning this approval is the seminal KEYNOTE-522 trial, a Phase III study that diverges from pre-2021 tactics heavily reliant on doxorubicin-cyclophosphamide and paclitaxel. Instead, this trial pioneers immunotherapy and chemotherapy, steering a significant treatment shift that departs conventional protocols. Clinicians now recognize pembrolizumab and chemotherapy as a superior initial line of attack, … Read more

ESMO 2023: GSK’s Jemperli beats Merck’s Keytruda in lung cancer survival trial

21 October 2023 by Anika Sharma

ESMO 2023: Jemperli outperforms Keytruda in lung cancer trial

In a groundbreaking clinical trial, GSK has achieved remarkable patient survival results with its PD-1 inhibitor, Jemperli, when compared to Merck’s Keytruda, a market leader. New data, presented at the European Society for Medical Oncology (ESMO) 2023 Congress, revealed a 25% lower risk of death among patients with newly diagnosed nonsquamous non-small cell lung cancer … Read more

Keytruda approved by FDA for early-stage lung cancer surgery, with a twist

19 October 2023 by Anika Sharma

FDA approves Keytruda for lung cancer surgery

In a groundbreaking development, the FDA has granted approval for Merck’s Keytruda to be employed in a continuous immunotherapy regimen for resectable non-small cell lung cancer (NSCLC) patients, both before and after surgery. This decision marks a significant shift in the treatment landscape for NSCLC, offering newfound hope to patients. Keytruda, a PD-1 inhibitor, has … Read more

Merck’s Keytruda extends survival of early lung cancer patients in trial, awaits FDA approval

10 October 2023 by Anika Sharma

Merck & Co.’s Keytruda has achieved a groundbreaking milestone in the treatment landscape for early-stage non-small cell lung cancer (NSCLC), a field previously described as “messy” by doctors. In a pivotal phase 3 trial, Keytruda demonstrated a remarkable overall survival advantage when administered both before and after surgery in patients with stage 2 to 3b … Read more

Keytruda shows promise in bladder cancer trial, Merck says

5 October 2023 by Anika Sharma

Merck’s immunotherapy drug, Keytruda, continues to demonstrate success in the field of bladder cancer. After securing FDA approvals for use in metastatic and non-muscle invasive bladder cancer, Keytruda has now delivered positive results in localized muscle-invasive and locally advanced urothelial carcinoma. In a phase 3 trial called the Ambassador trial, Keytruda proved effective in lowering … Read more

Padcev-Keytruda combo cuts death risk in first-line bladder cancer

22 September 2023 by Anika Sharma

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As Seagen readies itself for its impending acquisition by Pfizer, a significant triumph emerges for the company’s cancer drug Padcev, which is partnered with Astellas. In a groundbreaking development, Padcev, when used in combination with Merck’s Keytruda, has achieved a pivotal victory in previously untreated metastatic bladder cancer. The study yielded remarkable results, demonstrating the … Read more

Keytruda-Lenvima combo fails to improve survival in two lung cancer trials

22 September 2023 by Anika Sharma

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Merck and Eisai’s collaborative effort with Keytruda and Lenvima faces yet another setback in their quest to combat cancer. Despite previous disappointments this year in melanoma, colorectal cancer, and head and neck squamous cell carcinoma trials, the duo has encountered yet another challenge, this time in non-small cell lung cancer (NSCLC). Keytruda, when combined with … Read more

Setbacks Continue: Merck and Eisai’s Ambitious Combo of Keytruda-Lenvima Stumble in Head and Neck Cancer Battle

25 August 2023 by Anika Sharma

Merck, Eisai, keytruda, Lenvima, Head and neck cancer,

In a somber development for the pharmaceutical world, Merck and Eisai find themselves facing yet another roadblock on their quest to revolutionize cancer treatment. The curtain has fallen on a high-stakes phase 3 trial involving their dynamic duo, Keytruda and Lenvima, leaving researchers and patients alike with unanswered questions. The spotlight was cast on their … Read more

Keytruda Gets Green Light from NHS for New Cancer ‘Basket’

21 August 202317 August 2023 by Anika Sharma

Keytruda, NHS, NICE, Microsatellite instability, Mismatch repair deficient (dMMR) mutations

MSD’s Keytruda (pembrolizumab) has secured a significant recommendation from the UK’s National Institute for Health and Care Excellence (NICE), signaling a groundbreaking moment in cancer immunotherapy evaluation. In a historic move, NICE has endorsed Keytruda based on results from a ‘basket trial,’ a novel approach that enrolls patients with varying tumor locations but sharing a … Read more

Mirati fires its CEO and announces a new lung cancer Krazati-Keytruda study strategy

9 August 2023 by SG Tylor

Mirati Shakes Up Leadership and Lung Cancer Trial Plan

Following the successful approval of the KRAS inhibitor Krazati, Mirati Therapeutics’ CEO David Meek has made an abrupt exit from the company, effective immediately. This leadership change was disclosed by Mirati on Tuesday alongside its second-quarter financial results. Notably, Krazati achieved $13.4 million in sales during this period, surpassing the expectations of Wall Street. The … Read more

Merck and Moderna Commence Phase III Study of V940 with KEYTRUDA for High-Risk Melanoma

27 July 2023 by SG Tylor

New Vaccine Combo May Cure Deadly Melanoma

Source – Merck Moderna and Merck announced the commencement of the pivotal Phase III randomized V940-001 clinical trial. This trial aims to evaluate the effectiveness of V940 (mRNA-4157), an investigational personalized neoantigen therapy (INT), when used in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as an adjuvant treatment for patients with resected high-risk (Stage IIB-IV) melanoma. … Read more

EU CHMP Grants Favorable Opinion to Merck’s Keytruda Combination for HER2-Positive Advanced Gastric Cancer

26 July 202323 July 2023 by SG Tylor

KEYTRUDA Combo: A New Hope for HER2-Positive Gastric Cancer Patients in the EU

Source – Merck A new hope for patients with advanced gastric or GEJ cancer that is positive for both HER2 and PD-L1 has emerged from the CHMP of the EMA. The CHMP has issued a positive opinion for a new combination therapy that includes KEYTRUDA, Merck’s immunotherapy drug that blocks the PD-1 pathway, plus trastuzumab, … Read more

Merck’s Keytruda fails a study for early stomach cancer following metastatic disease victory

23 June 202323 June 2023 by SG Tylor

Source – Merck Inhibiting immune checkpoints hasn’t been very effective against stomach cancer. Merck has now added another failure to the mix. On June 20, 2023, Merck said that Keytruda, a treatment for resectable stomach and gastroesophageal junction (GEJ) adenocarcinoma, did not make a significant difference in terms of preventing tumors from recurring after surgery. … Read more

Keytruda Triumphs: Promising Progression-Free Survival in HER2-Positive Gastric Cancer

5 July 202318 June 2023 by SG Tylor

Source: Merck Merck’s renowned cancer drug, Keytruda, may soon see an updated label for its effectiveness in treating HER2-positive stomach cancer. Promising results from a combination study demonstrate its ability to prevent tumor progression. Keytruda initially received accelerated approval from the FDA in 2021 based on data showing tumor shrinkage. However, its continued approval relies … Read more

FDA accepts Merck’s application for Keytruda plus chemo in liver cancer

9 June 2023 by SG Tylor

The FDA has granted acceptance to Merck’s application for the popular drug Keytruda, in combination with standard-of-care chemotherapy (gemcitabine plus cisplatin), for the treatment of biliary tract cancer (BTC). The application is supported by data from the phase 3 KEYNOTE-966 trial involving 1,069 patients, which demonstrated that Keytruda significantly improved survival compared to chemotherapy alone. … Read more

Prelude Focuses on SMARCA in AbCellera Deal and Trims Its Portfolio by Dropping Two Phase 1 Candidates

2 November 2023 by Anika Sharma

Prelude Shifts Focus, Cuts Phase 1 Drugs in New Deal

Prelude Therapeutics is undergoing a strategic shift, significantly streamlining its clinical pipeline to focus on the promising potential of its SMARCA2 degrader and CDK9 inhibitor in cancer treatment. The company has identified PRT3789, a first-in-class highly selective degrader of the SMARCA2 protein, as its “top priority.” Prelude aims to generate initial proof-of-concept data for this … Read more

AbbVie CEO reveals why it passed on Daiichi’s cancer drug

31 October 2023 by Anika Sharma

AbbVie CEO Rich Gonzalez has revealed the company’s stance on the recent ADC transaction involving Daiichi and Merck. Despite being aware of the opportunity, AbbVie decided to prioritize its internally-developed antibody-drug conjugate (ADC), ABBV-400, which is currently in a phase 1 trial for solid tumor patients. Gonzalez expressed confidence in the capabilities of ABBV-400, emphasizing … Read more

Roche’s TIGIT Therapy: ESMO Reveals Ongoing Commitment

30 October 2023 by Anika Sharma

Roche is taking a steadfast position in the realm of TIGIT-class therapies, even in the face of fluctuating data and industry developments. The commitment to TIGIT, a checkpoint inhibitor, is evident from Roche’s recent SKYSCRAPER-01 trial, which inadvertently disclosed promising results. This trial investigated a combination featuring Roche’s anti-TIGIT antibody tiragolumab in patients with first-line … Read more

GSK’s Jemperli Shows Promise in Endometrial Cancer Trial – FDA Label Expansion on the Horizon

30 October 2023 by Anika Sharma

GSK's Jemperli: Promising Endometrial Cancer Results

GSK has achieved a significant milestone with its PD-1 inhibitor, Jemperli, in the treatment of endometrial cancer, potentially opening the door to a wider patient population. The phase 3 RUBY trial has demonstrated that combining Jemperli with chemotherapy significantly prolongs the survival of patients with primary advanced or first recurrent endometrial cancer. GSK’s Head of … Read more

Merck boosts revenue outlook on COVID-19 pill Lagevrio demand

26 October 2023 by Anika Sharma

Merck ups revenue forecast on Lagevrio sales | Pharma News

In a surprising turn of events, Merck’s COVID-19 antiviral pill, Lagevrio, has defied expectations by generating an astounding $640 million in sales during the third quarter. Analysts had previously projected a more modest $120 million in sales, making this performance a significant shock. During an earnings call, Merck did not specifically address Lagevrio’s sales surge, … Read more

Daiichi and AstraZeneca expand ADC pipelines after Enhertu triumph

26 October 2023 by Anika Sharma

Daiichi, AZ grow ADC portfolios post Enhertu | Pharmtales

At the European Society for Medical Oncology (ESMO) Congress, Daiichi Sankyo made a significant impact by striking a $4 billion upfront deal with Merck & Co., granting them rights to Daiichi’s next three promising antibody-drug conjugate (ADC) candidates. “We realize we have a core competency in drug discovery, ADC technology and we understand that a … Read more

Elektrofi lands $20M from Eli Lilly for subcutaneous drug partnership

24 October 2023 by Anika Sharma

Elektrofi gets $20M from Lilly for drug deal

Eli Lilly is collaborating with Elektrofi, a drug delivery specialist, to explore the potential of Elektrofi’s microparticle formulation technology in the development of next-generation subcutaneously administered therapies. Under the agreement, Lilly will provide an initial payment of $20 million to secure exclusive rights to three undisclosed therapeutic targets. Subsequently, Lilly will assume responsibility for clinical … Read more

Merck Drops Two Cancer ADCs from Kelun Deal, Focuses on Daiichi Sankyo

23 October 2023 by Anika Sharma

Merck Ends Some ADC Development with Kelun

Merck & Co. is refining its strategy in the realm of antibody-drug conjugates (ADCs). Shortly after a $4 billion acquisition of three assets from Daiichi Sankyo, Merck has chosen not to proceed with two preclinical ADCs offered by Kelun-Biotech. Over the past 18 months, China’s Kelun has played a prominent role in Merck’s expansion into … Read more

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