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Merck MRK announced that a phase study evaluating its Daiichi Sankyo-partnered HER3-directed DXd antibody drug conjugate (ADC), patritumab deruxtecan, for treating EGFR-mutated non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival (PFS).
The HERTHENA-Lung02 evaluated the efficacy and safety of patritumab deruxtecan versus pemetrexed and platinum chemotherapy for treating locally advanced or metastatic EGFR-mutated NSCLC in patients who had received prior EGFR tyrosine kinase inhibitor treatment. In the study, patritumab deruxtecan demonstrated a statistically significant improvement in PFS — the study’s primary endpoint — versus platinum plus pemetrexed induction chemotherapy.
As regards overall survival, a key secondary endpoint of the study, the data were immature at the time of the analysis. The study will continue to further assess overall survival.
Patients with metastatic EGFR-mutated NSCLC who are initially treated with an EGFR TKI sometimes experience disease progression. This creates a need for therapies like patritumab deruxtecan as treatment options for this type of lung cancer in the second-line setting are limited.
Merck plans to discuss the data with regulatory authorities to decide the next steps.
Merck’s stock has risen 8.5% so far this year compared with an increase of 25.9% for the industry.
More on MRK’s Patritumab Deruxtecan
A biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated NSCLC is already under review in the United States supported by data from the HERTHENA-Lung01 pivotal phase II study.
In June, the FDA issued a complete response letter to the BLA based on observations made after the inspection of a third-party manufacturing facility. The FDA has not requested any additional efficacy/safety studies, nor has it identified any issues related to the safety and efficacy of the candidate. Merck is working closely with the FDA and the third-party manufacturer to resolve the issue.
Merck’s Deal With Daiichi Sankyo
Merck acquired global co-development and co-commercialization rights to patritumab deruxtecan/MK-1022 and two other ADCs, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400 from Japan’s Daiichi Sankyo in October last year for a total potential consideration of up to $22 billion. While raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer, ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.
Daiichi Sankyo has retained exclusive rights for the development of the candidates in Japan. In August this year, Merck expanded its deal with Daiichi to co-develop and co-commercialize MK-6070, an investigational T-cell engager targeting delta-like ligand 3, which it obtained from its acquisition of Harpoon Therapeutics.
Other Companies Making ADC Products
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancer, being developed utilizing its DXd ADC technology. It markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca AZN. Daiichi Sankyo and AstraZeneca have also developed datopotamab deruxtecan (Dato-DXd), a TROP2-directed ADC. Dato-DXd is under FDA review for advanced nonsquamous NSCLC as well as previously treated metastatic HR-positive, HER2-negative breast cancer. The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Pfizer PFE also has a strong portfolio of ADC drugs, which were added with last year’s acquisition of Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio. Adcetris, Padcev, Tukysa and Tivdak contributed $279 million, $394 million, $121 million and $33 million, respectively, to Pfizer’s oncology revenues in the second quarter. Pfizer is particularly witnessing strong demand for Padcev.
MRK’s Rank and Stock to Consider
Merck has a Zacks Rank #4 (Sell) currently.
Merck & Co., Inc. Stock Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
A top-ranked large drugmaker is Eli Lilly LLY, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for 2024 have risen from $13.71 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.42 to $23.97 per share over the same timeframe. LLY’s stock is up 55.5% year to date.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
Zacks Investment Research
Wednesday, the FDA approved Merck & Co Inc’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The approval marks the first indication for Keytruda in MPM in the U.S.
Also Read: Merck/Daiichi Sankyo Partnered Lung Cancer Candidate Meets Primary Goal In Late-Stage Study.
MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest.
The approval is based on pivotal Phase 2/3 IND.227/KEYNOTE-483 trial data.
Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% compared to chemotherapy alone.
Median OS was 17.3 months for Keytruda plus chemotherapy versus 16.1 months for chemotherapy alone.
Keytruda plus chemotherapy also significantly improved progression-free survival (PFS) versus chemotherapy alone.
The overall response rate (ORR) was significantly higher for Keytruda plus chemotherapy versus chemotherapy alone (52% versus 29%), respectively.
Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving Keytruda in combination with pemetrexed and platinum chemotherapy.
In August, Merck discontinued two Keytruda late-stage studies.
Price Action: MRK stock is trading 0.04% higher at $118.34 at the last check on Wednesday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Adds details on the deal in paragraphs 2-4
Sept 18 (Reuters) - Healthcare company Organon OGN.N said on Wednesday it has agreed to acquire skin therapy developer Dermavant, a unit of Roivant ROIV.O, for up to $1.2 billion.
Organon will make an upfront payment of $175 million, as well as milestone payments of $75 million and up to $950 million upon achievement of certain commercial milestones.
Dermavant's VTAMA psoriasis cream was approved by the U.S. Food and Drug Administration in May 2022. Psoriasis is a common chronic inflammatory skin disease.
The company expects to close the transaction in the fourth quarter of this year.
(Reporting by Sneha S K; Editing by Vijay Kishore)
(( Sneha.SK@thomsonreuters.com ;))
Keywords: DERMAVANT-M&A/ORGANON (UPDATE 1)
The recommendations of Wall Street analysts are often relied on by investors when deciding whether to buy, sell, or hold a stock. Media reports about these brokerage-firm-employed (or sell-side) analysts changing their ratings often affect a stock's price. Do they really matter, though?
Before we discuss the reliability of brokerage recommendations and how to use them to your advantage, let's see what these Wall Street heavyweights think about Merck (MRK).
Merck currently has an average brokerage recommendation (ABR) of 1.23, on a scale of 1 to 5 (Strong Buy to Strong Sell), calculated based on the actual recommendations (Buy, Hold, Sell, etc.) made by 26 brokerage firms. An ABR of 1.23 approximates between Strong Buy and Buy.
Of the 26 recommendations that derive the current ABR, 23 are Strong Buy, representing 88.5% of all recommendations.
Brokerage Recommendation Trends for MRK
The ABR suggests buying Merck, but making an investment decision solely on the basis of this information might not be a good idea. According to several studies, brokerage recommendations have little to no success guiding investors to choose stocks with the most potential for price appreciation.
Are you wondering why? The vested interest of brokerage firms in a stock they cover often results in a strong positive bias of their analysts in rating it. Our research shows that for every "Strong Sell" recommendation, brokerage firms assign five "Strong Buy" recommendations.
This means that the interests of these institutions are not always aligned with those of retail investors, giving little insight into the direction of a stock's future price movement. It would therefore be best to use this information to validate your own analysis or a tool that has proven to be highly effective at predicting stock price movements.
Zacks Rank, our proprietary stock rating tool with an impressive externally audited track record, categorizes stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), and is an effective indicator of a stock's price performance in the near future. Therefore, using the ABR to validate the Zacks Rank could be an efficient way of making a profitable investment decision.
Zacks Rank Should Not Be Confused With ABR
Although both Zacks Rank and ABR are displayed in a range of 1-5, they are different measures altogether.
Broker recommendations are the sole basis for calculating the ABR, which is typically displayed in decimals (such as 1.28). The Zacks Rank, on the other hand, is a quantitative model designed to harness the power of earnings estimate revisions. It is displayed in whole numbers -- 1 to 5.
Analysts employed by brokerage firms have been and continue to be overly optimistic with their recommendations. Since the ratings issued by these analysts are more favorable than their research would support because of the vested interest of their employers, they mislead investors far more often than they guide.
On the other hand, earnings estimate revisions are at the core of the Zacks Rank. And empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
Furthermore, the different grades of the Zacks Rank are applied proportionately across all stocks for which brokerage analysts provide earnings estimates for the current year. In other words, at all times, this tool maintains a balance among the five ranks it assigns.
Another key difference between the ABR and Zacks Rank is freshness. The ABR is not necessarily up-to-date when you look at it. But, since brokerage analysts keep revising their earnings estimates to account for a company's changing business trends, and their actions get reflected in the Zacks Rank quickly enough, it is always timely in indicating future price movements.
Is MRK Worth Investing In?
In terms of earnings estimate revisions for Merck, the Zacks Consensus Estimate for the current year has declined 0% over the past month to $8.01.
Analysts' growing pessimism over the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates lower, could be a legitimate reason for the stock to plunge in the near term.
The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #4 (Sell) for Merck. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here
Therefore, it could be wise to take the Buy-equivalent ABR for Merck with a grain of salt.
Zacks Investment Research
By Colin Kellaher
Merck & Co. has won its first U.S. approval for use of its blockbuster cancer drug Keytruda in patients with malignant pleural mesothelioma, a rare cancer that grows in the membrane that lines the walls of the chest and lungs.
Merck on Wednesday said the Food and Drug Administration approved Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma.
The Rahway, N.J., drugmaker said the approval is based on results from a Phase 3 study in which Keytruda plus chemotherapy showed a statistically significant improvement in overall survival versus chemotherapy alone.
Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications worldwide and generated sales of more than $25 billion last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
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