Pfizer’s Ibrance Improves Survival in New Breast Cancer Indication

 

Pfizer, facing increasing pressure from Novartis, is touting a Phase III win for Ibrance as the first clinical evidence supporting the CDK4/6 inhibitor class’ use in patients with a specific type of breast cancer.

Pfizer’s Ibrance has shown efficacy in a new type of breast cancer, potentially expanding the patient population the blockbuster medicine can be used for. The Phase III clinical win comes at a pivotal time for Pfizer, as Novartis’ Kisqali was recently approved for another group of breast cancer patients.

Ibrance extended median progression-free survival (PFS) by more than 50% in patients with first-line HR+, HER2+ metastatic breast cancer when combined with anti-HER2 and endocrine therapy. The Phase III PATINA trial compared Ibrance to standard of care first-line maintenance therapy after chemotherapy. Median PFS was 44.3 months for the Ibrance group as compared to 29.1 months for those on the standard of care regimen.

Pfizer touted the results as the first time a CDK4/6 inhibitor has shown benefit in this group of patients, which represents about 10% of all breast cancers.

Ibrance was first approved in 2015 for treating postmenopausal woman with breast cancer. It has since racked up three more FDA nods for HR+, HER2- metastatic breast cancer; first-line HR+, HER2- metastatic breast cancer; and men with HR+, HER2- metastatic breast cancer.

Pfizer has had a clear headstart with its CDK4/6 inhibitor over Novartis, which followed with an initial approval for Kisqali in 2017 for HR+/HER2- metastatic breast cancer. A year later, the drug was approved for HR+/HER2- advanced breast cancer, and in September this year it got another nod in HR+/HER2- early breast cancer.

Ibrance brought in $4.75 billion worldwide for Pfizer in 2023, an increase of 7% over the prior year. Meanwhile, Novartis clocked $2.08 billion in net sales for Kisqali in the same year representing a 69% increase.

https://www.biospace.com/drug-development/pfizers-ibrance-improves-survival-in-new-breast-cancer-indication

Lilly, Pfizer Execs Sing Optimistic Tune on Incoming Admin After Trump Dinner

 

A week after dining with Trump and his team at Mar-a-Lago, leaders at Pfizer and Eli Lilly have publicly stated that they intend to collaborate with the incoming administration on key issues affecting the pharma industry.

In separate interviews on Tuesday, top executives at Eli Lilly and Pfizer expressed their openness to working with the incoming Trump administration on key issues affecting the pharma industry.

These statements come after pharma chiefs sat down with President-elect Donald Trump for dinner last week at his Mar-a-Lago residence—alongside a representative from the trade group Pharmaceutical Research and Manufacturers of America—as reported by Axios. Trump’s incoming chief of staff Susie Wiles was also at the dinner, though it remains unclear what exactly was discussed.

In a Tuesday interview with Fierce Pharma at the Economic Club of Washington, D.C., Lilly CEO David Ricks said that raising drug prices in other developed countries is key to lowering costs in the U.S., and that this is likely to be one of the levers that Trump’s incoming healthcare team will be moving.

However, in an investor note citing the Fierce article, Leerink Partners analysts questioned how possible such a move might be, pointing out that “it will be difficult to raise ex-US prices.”

“Ex-US governments control drug prices on a country-by-country basis via negotiations on individual drugs,” the analysts wrote, adding that “since their health systems are government-run, they also pay much lower prices for healthcare in general.” These are some of the reasons why, they said, “We don’t see a simple way to force other countries to pay higher prices for drugs given disparate health technology assessment entities and pricing constructs.”

Drug pricing has been a flashpoint for the industry and the government, particularly in the years since outgoing President Joe Biden signed the Inflation Reduction Act into law in 2022. The centerpiece of the Act is the drug price negotiation program, which allows the Centers for Medicare and Medicaid Services (CMS) to renegotiate the prices for some of the most widely prescribed drugs—with their new costs set to begin taking effect in 2026.

In August 2024, the CMS released the final agreed-upon maximum fair prices for the first 10 drugs to come under this program. Biden and Vice President Kamala Harris touted the negotiations as a big win for their administration—and the American people—projected to generate around $6 billion in Medicare savings in 2026.

Analysts have been largely skeptical, however, particularly as many of the drugs had been selling far below their list prices even before the negotiations kicked off.

Ricks added in the Fierce interview that the industry is also looking forward to seeing how the Trump administration will change or influence “the regulatory situation,” which he said has shifted “in a negative way” for pharma under Biden.

Meanwhile, in an interview with Reuters, Pfizer Chief Sustainability Officer Caroline Roan said that the pharma will work with the incoming Trump administration on matters regarding the climate emergency and drug accessibility. “We’re going to roll up our sleeves and we’re going to find common ground. And I believe that’s possible.”

Despite increasing polarization around climate and vaccine science, Pfizer will continue to advance innovative products to ensure patients will have access to effective therapeutic and immunization options, Roan added.

Also on Tuesday, Trump announced that he will nominate Andrew Ferguson as the chair of the Federal Trade Commission under his administration, an appointment that according to the Associated Press could be good for dealmaking in the pharma industry.

https://www.biospace.com/policy/lilly-pfizer-execs-sing-optimistic-tune-on-incoming-admin-after-trump-dinner

Keros shares collapse on ‘unanticipated’ setback for lung disease drug

 

• Keros Therapeutics shares plummeted Thursday after the company said researchers conducting a Phase 2 study have stopped giving patients the two highest doses of its lead experimental drug because of reports of excess fluid buildup in the pericardial sac around the heart.

• The Tropos trial is designed to test three doses of Keros’ cibotercept in patients with pulmonary arterial hypertension who are already receiving other therapy for the condition. After reviewing the reports of pericardial effusion, company executives and independent monitors decided the trial could go on for patients receiving the lowest dose, but halted research of higher doses.

• “This is an unanticipated observation in this trial,” CEO Jasbir Seehra told analysts and investors on a conference call. “We will be doing further work to try to understand it, but it is unanticipated based upon all the biology that we understand from preclinical and healthy volunteer studies.”

Investors had viewed cibotercept as a potential improvement on Merck’s Winrevair, which analysts view as a potential $5 billion-a-year seller. Part of the case for the Keros drug was the possibility for better safety than Winrevair as well as a chance at superior efficacy at higher doses.

Though Keros will continue to test a lower dose in the Tropos study, investors clearly have lost faith in the medicine. Keros shares tumbled 77% early Thursday, wiping out more than $2 billion of market value.

“We believe the clinical setback will make it difficult to regain investor interest in cibotercept, which was the company’s lead program and main value driver,” William Blair analyst Matt Phipps wrote in a note to investors. While the lower dose “could show a favorable benefit/risk profile, we believe it will take more data to convince investors and physicians” and ultimately to compete with Merck, he said.

Before the latest setback, Keros had been one of the most successful initial public offerings of the last four years, with its shares surging more than 300% from the company’s IPO price of $16, according to BioPharma Dive data. The stock traded at about $16 early Thursday after closing at almost $69 on Wednesday.

Keros had benefited in part from the success of Merck, which won approval for Winrevair in March and released more positive data in November. Merck’s drug is “transformative” for patients, and the case for buying Keros stock was that the company had an even better option in development, Cantor Fitzgerald analyst Prakhar Agrawal wrote when he initiated coverage of Keros in October.

Though cibotercept is the company’s lead drug, Keros does have others in its pipeline. An experimental blood disease drug called elritercept recently drew the eye of Takeda, which agreed to pay $200 million for rights outside of China, Hong Kong and Macau.

https://finance.yahoo.com/news/keros-shares-collapse-unanticipated-setback-110200001.html

Kenvue stock gains on report activist Starboard nominates five for board

 Kenvue (NYSE:KVUE) rose 1.3% after a report that activist Starboard Value has privately nominated five board candidates

https://seekingalpha.com/news/4385978-kenvue-gains-on-report-activist-starboard-nominates-five-for-board

Trevi Up as Current Study Sample Size Confirmed Correct

 On Thursday, Trevi Therapeutics, Inc. (NASDAQ:TRVI) announced the outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough, which requires no change to the current sample size for the trial (N=160).

The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough.

The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured with an objective cough monitor (VitaloJAK). The trial will also explore secondary endpoints, including patient-reported outcome measures for cough.

The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025.

The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment.

Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater.

The other two potential pre-specified outcomes of the SSRE analysis were increased sample size or futility.

“We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned,” said Jennifer Good, President and CEO of Trevi Therapeutics. “This positive SSRE outcome is reassuring and confirms the key powering assumptions of the trial design. We believe this is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough...”

https://finance.yahoo.com/news/why-cough-focused-trevi-therapeutics-144722170.html

Producer Price Inflation Comes In 'Red Hot' In November

 Following yesterday's reported re-ignition in consumer price inflation (despite people seemingly being exuberant that it was 'as expected' - we don't remember The Fed's mandate being stable prices in line with consensus expectations?), this morning's producer prices were expected to accelerate further also to +2.6% YoY from +2.4% YoY.

But it didn't...

Headline PPI surged 0.4% MoM (+0.2% MoM exp) - biggest MoM jump since June - which lifted the YoY rise in producer prices to +3.0% - far above expectations and the highest since Feb 2023...

Source: Bloomberg

Headline PPI's big jump was driven by food costs (rising at their fastest since Nov 2022)...

Source: Bloomberg

A quarter of the November rise in prices for final demand goods is attributable to a 54.6-percent jump in the index for chicken eggs.

Prices for fresh and dry vegetables, fresh fruits and melons, processed poultry, non-electronic cigarettes, and residential electric power also increased. In contrast, the index for oilseeds declined 4.7 percent. Prices for diesel fuel and for primary basic organic chemicals also decreased.

Services costs are accelerating fast on a YoY basis and Energy's deflationary pressure is evaporating rapidly...

Source: Bloomberg

Not only was much of the PPI report better than expected, the underlying components were too.

The percentage of those rising on an annual basis is at 80%.

As the chart shows, this is typically consistent with PPI remaining elevated.

Spot the difference (food costs just hit a new record high)...

Source: Bloomberg

Core PPI (ex-food and energy) rose 0.2% MoM as expected but the YoY core PPI jumped dramatically to +3.4% YoY - also the hottest since Feb 2023...

Source: Bloomberg

Given the resurgence in money supply, it should not be a surprise that PPI (and CPI) are on the rise again...

Source: Bloomberg

Does that look like an inflationary backdrop that needs a rate-cut next week?

https://www.zerohedge.com/markets/producer-price-inflation-comes-red-hot-november

Supreme Court Rules 9–0 Federal Judges Cannot Second-Guess Visa Revocations

 by Matthew Vadum via The Epoch Times (emphasis ours),

The U.S. Supreme Court ruled unanimously on Dec. 10 that federal courts may not review the federal government’s decision to revoke an immigration visa.

The court’s 9–0 opinion in Bouarfa v. Mayorkas was written by Justice Ketanji Brown Jackson. The respondent is U.S. Department of Homeland Security (DHS) Secretary Alejandro Mayorkas.

The U.S. Supreme Court in Washington on Dec. 2, 2024. Madalina Vasiliu/The Epoch Times

In the case, the DHS revoked a Palestinian man’s visa after it found he previously attempted to pass off another one of his marriages as legitimate to obtain permanent resident status. Because the government determined he engaged in fraud before, the current marriage was deemed fraudulent, and his visa, which had been approved, was canceled.

The petitioner, Amina Bouarfa, a U.S. citizen, married noncitizen Ala’a Hamayel. They produced three children, all of whom are U.S. citizens, according to Bouarfa’s petition to the Supreme Court.

Around three years after they married, Bouarfa filed an immigration petition to classify her husband as an immediate relative, which would make him eligible for adjustment to permanent resident status.

In 2015, U.S. Citizenship and Immigration Services (USCIS), an agency of the DHS, approved the wife’s petition, but in 2017 it moved to revoke its approval, citing evidence Hamayel’s first marriage was fraudulent. The agency said if it had known of the sham marriage, it would not have granted the petition.

Bouarfa disputed the decision the same year and the Board of Immigration Appeals ruled against her in 2021, finding federal law barred approval of the petition.

In January 2022, Bouarfa sued in a federal district court in Florida, requesting a review of the board’s decision under the Administrative Procedure Act, which governs how government agencies create and enforce rules. The court dismissed the case, finding it lacked authority to hear it.

A panel of the U.S. Court of Appeals for the 11th Circuit affirmed, holding that federal law precludes judicial review of the revocation of a visa and that revocations are “discretionary—no matter the basis for revocation.”

In the Supreme Court’s ruling, Jackson wrote that the decision to revoke involved “a quintessential grant of discretion” to DHS that judges are unable to review.

Jackson wrote that the law provides that the DHS secretary “may, at any time, for what he deems to be good and sufficient cause, revoke the approval of any [visa] petition.”

Despite this, Bouarfa still has options, as the government acknowledges. “Nothing prohibits a citizen from filing another petition on behalf of the same relative,” the justice wrote, adding that nothing in the law requires the secretary to uphold the sham marriage determination.

In fact, Bouarfa has already re-filed and if her petition is turned down again because of the sham marriage finding, she may seek judicial review, Jackson added.

The Supreme Court affirmed the ruling of the 11th Circuit.

The Epoch Times reached out for comment to the U.S. Department of Justice, which represents the DHS, and Bouarfa’s attorney, Samir Ibrahim Deger-Sen of Latham and Watkins in New York City. No replies were received by publication time.

https://www.zerohedge.com/political/supreme-court-rules-9-0-federal-judges-cannot-second-guess-visa-revocations