10 states still have COVID emergency orders in place

 New York Gov. Kathy Hochul (D) announced Monday that she will end the state’s COVID-19 state of emergency amid falling case numbers and rising criticism.

While the COVID-19 pandemic has faded as a major concern for much of the American public, there are still 10 states across the U.S. with emergency orders in place.

States first declared public emergencies in March 2020 and governors kept renewing them until around the spring of 2022, when the pandemic eased after a brutal winter surge driven by the omicron variant.

Unless renewed, nearly all of the emergency declarations in the remaining 10 states will expire by the beginning of 2023.

Here are the 10 states with orders still in effect, as of Sept. 12.

California

Gov. Gavin Newsom (D) extended the COVID-19 state of emergency in June. But he has also been “responsibly winding down” pandemic executive orders, leaving 5 percent of COVID-related provisions in place, according to a June 17 statement from Newsom’s office.

“As California navigates the evolving pandemic, the state remains laser-focused on keeping Californians safe while advancing our ongoing recovery,” Newsom said. “We’re continuing to deploy proven strategies and programs that allow us to swiftly and effectively respond to changing pandemic conditions, take on equity gaps, and keep us moving forward.”

Connecticut

The state has an emergency declaration in place for COVID-19 until Dec. 28, 2022, or until the federal government’s public health emergency ends, whichever comes first.

Gov. Ned Lamont (D) said in a letter to the state legislature that it was beneficial for the state to keep the emergency, primarily to assist with food insecurity.

During the emergency, the federal government is authorized to distribute more assistance through the Supplemental Nutrition Assistance Program.

Delaware

Gov. John Carney (D) last renewed the public health emergency for COVID-19 on Aug. 19. It will expire on Sept. 18 unless renewed.

Washington

With the state experiencing declining COVID-19 death rates, Gov. Jay Inslee (D) announced he would end the public health emergency on Oct. 31.

“We’ve come a long way the past two years in developing the tools that allow us to adapt and live with COVID-19,” Inslee said in a statement.

“Ending this order does not mean we take it less seriously or will lose focus on how this virus has changed the way we live. We will continue our commitments to the public’s well-being, but simply through different tools that are now more appropriate for the era we’ve entered.”

New Mexico

Gov. Michelle Lujan Grisham (D) extended the state’s public health emergency for a month starting on Aug. 17. It will expire on Sept. 15 unless renewed.

Upon renewing the order, she wrote: “Due to the continued spread of COVID-19, it is necessary for all branches of State government to continue taking actions to minimize transmission of COVID-19 and reduce its attendant physical and economic harms.”

Texas

Gov. Greg Abbott (R) last renewed the state’s public health emergency in August and will have to decide whether to renew it again later this month.

Abbott said the COVID-19 pandemic still presents an “imminent threat of disaster for all counties in the State of Texas.”

Illinois

Gov. JB Pritzker (D) extended the public health emergency in August and it will remain in effect until at least Sept. 17.

Pritzker said more than 34,500 Illinoisans have died in the pandemic and added “predicting what will happen in the future in this pandemic continues to be a difficult task.”

Kansas

The Kansas legislature passed a law this year extending emergency powers through January 2023, primarily to assist overburdened health care workers.

West Virginia

Gov. Jim Justice (R) first declared a public health emergency in March 2020 and has yet to lift the order. He continues to give regular updates to the public about the state’s pandemic response.

Rhode Island

Gov. Daniel McKee extended the public health emergency earlier this month, citing “the dangers to health and life posed by SARS-CoV-2.” It will expire after Sept. 30 unless renewed.

https://thehill.com/policy/healthcare/3638892-these-10-states-still-have-covid-emergency-orders-in-place/

FDA schedules meeting on OTC birth control pill application

 he Food and Drug Administration (FDA) has scheduled a joint meeting to discuss pharmaceutical company Perrigo’s application for what could be the first over-the-counter (OTC) daily birth control pill available in the U.S., the company announced Monday.

The joint meeting will be held on Nov. 18 with the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, according to Perrigo.

If approved by the FDA, Perrigo’s progestin-only daily pill would be the first non-prescription birth control pill available in the U.S. Perrigo filed its application to move its birth control pill from prescription to OTC in July.

The FDA declined to provide further comment on the meeting when reached by The Hill.

Consumer Healthcare Products Association (CHPA), a U.S. health care trade association, welcomed news of the FDA’s scheduled meeting.

“Pathways like Rx-to-OTC switch are instrumental in carrying out that mission on behalf of our member companies and American consumers,” said CHPA’s CEO Scott Melville. “We are pleased to see FDA evaluating broadened access to oral contraception and we look forward to sharing industry perspectives at this joint Committee meeting in November.”

Many countries in Latin America, Asia and Africa already allow for OTC birth control pills to be sold.

Perrigo filed its application just weeks after the Supreme Court overturned Roe v. Wade, leading to several states in the U.S. enacting total or near-total abortion bans. Supreme Court Justice Clarence Thomas’s concurring opinion sparked concerns that protected access to contraceptives could also be overturned.

The House in July passed the Right to Contraception Act, with eight Republicans joining Democrats in voting “yes.” The bill would codify access to contraception — including oral birth control, condoms and intrauterine devices — on the federal level.

Senate Democrats Ed Markey (Mass.), Patty Murray (Wash.), Mazie Hirono (Hawaii) and Tammy Duckworth (Ill.) sought unanimous consent to quickly pass the bill in July, but were blocked by Republican Sen. Joni Ernst (Iowa), though she herself has expressed support for expanded birth control access. Ernst argued that the bill went beyond just guaranteeing access to contraception.

https://thehill.com/policy/healthcare/3639058-fda-schedules-meeting-on-otc-birth-control-pill-application/

POINT Bio Shares Jump After Updated Data From Prostate Cancer Candidate

 

• POINT Biopharma Global Inc 
  PNT+21.1%+ Free Alerts
   shared updated efficacy and safety data from the 27-patient lead-in cohort for the Company's phase 3 SPLASH trial evaluating PNT2002 for metastatic castration-resistant prostate cancer (mCRPC). 
• The newly released data based on a median follow-up of 11.7 months revealed a median radiographic progression-free survival (rPFS) of 11.5 months, compared to the control arm benchmarks of 3.5–4.2 months.
• Median overall survival had not been reached with an 11.7-month median duration of follow-up from the time of enrollment.
• A best radiographic objective response (CR, PR) was achieved in 60% of the 10 participants with the evaluable disease at baseline.
• From a median baseline PSA (ng/mL) of 22 (range 0.3–701.0), 11 (42%) participants achieved a PSA50 response.
• PNT2002 was well tolerated, with no treatment-related deaths and few treatment-related AEs of grade 3 or higher.

https://www.benzinga.com/general/biotech/22/09/28832998/point-biopharma-shares-jump-after-updated-efficacy-safety-data-from-prostate-cancer-candidate

PolyPid to Present Phase 2 D-PLEX Clinical Data

 Efficacy Data of D-PLEX100 in the Prevention of Post-Abdominal Surgery Incisional Infection will be Presented During a Podium Presentation

 PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Phase 2 clinical data for D-PLEX100 will be highlighted in a podium presentation at the European Society for Coloproctology (ESCP) Scientific Conference to be held on September 21-23, 2022, in Dublin, Ireland.

European Society for Coloproctology Scientific Conference:

Title:	D-PLEX100, a novel doxycycline formulation that provides high, local concentrations of antibiotic activity for 30 days to reduce surgical site infections
Presenter:	Anthony J. Senagore, M.D., Senior Medical Director, PolyPid
Date:	Wednesday, September 21, 2022, part of the Modern Colorectal Surgeon session

The abstract will be available on  www.polypid.com/publications/ following the presentation.

https://finance.yahoo.com/news/polypid-announces-presentation-phase-2-110000572.html

Colorectal Cancer Burden on the Rise in Developed Countries

 Colorectal cancer (CRC) has been on the rise among higher income countries -- and that trend is expected to continue for both incidence and mortality rates, a global study found.

More than 1.9 million new CRC cases arose across 185 countries in 2020, with an estimated 930,000 million CRC-related deaths, which accounted for 10.7% of all cancers and 9.5% of cancer-related deaths, reported Eileen Morgan, PhD, of the International Agency for Research on Cancer in Lyon, France, and colleagues in a paper published in Gut.

By 2040, the burden of CRC was projected to increase by 63%, reaching 3.2 million new cases and 1.6 million deaths, with some 80% expected to occur in countries like the United States with a high or very high level of human development index (HDI).

Incidence rates were four times higher in countries with very high HDI in 2020 compared with low HDI countries for both males (35.4 vs 8.2 per 100,000) and females (24.4 vs 6.7 per 100,000).

CRC mortality rates followed a similar pattern, with Eastern Europe showing the highest rates (20.2 per 100,000 males) whereas Southern Asia had the lowest rates (2.5 per 100,000 females).

"Moreover, a close to 3% decline in incidence rates per annum would be needed to keep the future number of cases to present (2020) levels," they noted. And while the largest relative spikes in new CRC cases are expected to occur among transitioning countries (low/medium HDI), absolute increases are predicted to impact high/very high HDI countries the most.

The highest CRC incidence was observed in Australia, New Zealand, and Europe (40.6 per 100,000 males), while the lowest incidence was in Africa and Southern Asian regions (4.4 per 100,000 females).

Across countries, a 10-fold variation was seen in incidence rates among males and females. Both incidence and mortality rates were higher among males.

"Variations in incidence were also observed within regions, for example, Hungary and Slovenia have among the highest rates in males in the Eastern and Southern regions of Europe," the researchers noted, which could reflect the timing of screening.

Reached for comment, Allen Kamrava, MD, of Cedars-Sinai Medical Center in Los Angeles, said "While the precision of these types of studies is low, it is sufficient for what the authors wish to accomplish, which is awareness and education."

"Given that CRC cancers are one of the most common cancers globally," Kamrava added, "raising awareness for proper screening and healthy behavior is a good thing."

CRC ranks third among the most common types of cancer worldwide and comes in second for cancer-related deaths, Morgan's group noted. Moreover, CRC is largely a preventable disease with modifiable risk factors, such as high alcohol or sugar beverage consumption, smoking, and diet (highly processed/junk foods).

Recently, CRC incidence – including more distal tumors and distant-stage disease – has been on the rise among younger individuals below age 50, especially in high-income countries such as the U.S., U.K., and Australia in addition to transitioning countries like Brazil. The American College of Gastroenterology and other organizations have responded by lowering the CRC screening age to 45.

Notably, in Morgan's study, 60.4% of all CRC diagnoses occurred between ages 50 and 74. Nearly 10% were diagnosed before age 50.

The researchers examined Global Cancer Observatory (GLOBOCAN) data from the year 2020 and used it to predict the number of CRC cases and deaths in 2040, which were stratified by age and sex. Predictions were calculated based on global demographic projections for 185 countries using the HDI. Researchers also extracted 2020 population data from the United Nations.

CRC was the most common cancer type in 18 countries, while CRC ranked second or third in 78 more. Six countries reported CRC was the most common cause of cancer-related death, while it came in among the top three leading causes of cancer-related deaths in 104 countries.

The authors acknowledged limitations to the data, specifying that findings and predictions based on extrapolations should be interpreted with caution. GLOBOCAN estimates were taken prior to the pandemic, therefore excluding any potential pandemic-related changes in diagnostic activity. Types of CRC or anatomical subsites were not assessed.

Disclosures

Morgan and co-authors did not disclose any conflicts of interest.

Primary Source

Gut

Source Reference: Morgan E, et al "Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN" Gut 2022; DOI: 10.1136/gutjnl-2022-327736.

https://www.medpagetoday.com/gastroenterology/coloncancer/100657

3 Adjuvant Immunotherapy Trials Flop in Renal Cell Carcinoma

 While pembrolizumab (Keytruda) has been approved as an adjuvant treatment for patients with high-risk renal cell carcinoma (RCC), three phase III studies presented at the European Society for Medical Oncology (ESMO) annual congress here failed to support the immune checkpoint inhibitor in this setting.

In Part A of the CheckMate-914 trial, the median disease-free survival (DFS) was not reached with nivolumab (Opdivo) plus ipilimumab (Yervoy) compared with 50.7 months with placebo in patients with localized RCC at high risk of post-nephrectomy relapse at a median follow-up of 37 months (HR 0.92, 95% CI 0.71-1.19, P=0.5347), reported Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center in New York City.

In the PROSPER trial, Mohamad E. Allaf, MD, of Johns Hopkins University in Baltimore, reported that with a median follow-up of 16 months, perioperative nivolumab failed to improve recurrence-free survival (RFS) compared with surgery alone in patients with high-risk RCC (HR 0.97, 95% CI 0.74-1.28, P=0.43).

In the IMmotion010 trial, median DFS was 57.2 months with adjuvant atezolizumab (Tecentriq) compared with 49.5 months with placebo in RCC patients at increased risk for recurrence after nephrectomy at a median follow-up of 44.7 months (HR 0.93, 95% CI 0.75-1.15, P=0.50), according to Axel Bex, MD, of University College London and the Netherlands Cancer Institute in Amsterdam. Results from IMmotion010 were also published in The Lancet.

Considering the results from IMmotion010 and "listening to the presentations ... on CheckMate-914, but also on PROSPER, which are contradictory to the results of pembrolizumab, I think it is clear that further studies are needed to clarify the role of immunotherapy in the adjuvant setting for RCC," Bex observed.

Addressing the IMotion010 and PROSPER studies, ESMO discussant Thomas Powles, MBBS, MD, of Barts Cancer Centre at St. Bartholomew's Hospital in London, said that while pembrolizumab has been shown to be strongly positive for DFS, with an overall survival (OS) signal that was supportive (although not mature), "patients should also be aware that other immune checkpoint inhibitors have been unable to replicate the pembrolizumab data ... creating new uncertainty in renal cancer."

CheckMate-914

Among 816 patients -- 405 randomized to nivolumab plus ipilimumab and 411 to placebo -- the estimated DFS rates at 24 months were 76.4% and 74.0%, respectively.

Any-grade treatment-related adverse events (TRAEs) were reported in 88.9% treated with nivolumab/ipilimumab versus 56.8% of patients in the placebo group, while grade ≥3 TRAEs were reported in 28.5% and 2.0%, respectively. TRAEs led to discontinuation in 29% and 1% of patients.

During a press briefing, Motzer was asked to put his findings into context considering the results of the KEYNOTE-564 trial, which led to FDA approval of pembrolizumab for adjuvant treatment of patients with high-risk RCC.

"They're different studies, and they have different designs, different duration of therapies," Motzer said. "I don't think this in any way takes away from standard-of-care pembrolizumab for patients in the adjuvant setting."

The results from CheckMate-914 will "help us learn in terms of moving forward -- the best direction to take," he added.

PROSPER

This trial, which randomized 819 patients to perioperative nivolumab (n=404) or surgery alone (n=415) from February 2017 to June 2021, was stopped early due to futility. Nivolumab 480 mg IV was administered every 4 weeks, with one dose prior to surgery followed by nine adjuvant doses. The control arm was followed by surveillance without a placebo.

OS data were not mature at the time of analysis, but OS was not statistically different between study arms (HR 1.48, 95% CI 0.89-2.48, P=0.93), Allaf reported.

Adverse events were similar to what has been seen in other nivolumab monotherapy trials, with 93% of patients in this arm experiencing an adverse event of any kind. More serious adverse events also occurred in the nivolumab arm (33% vs 13%).

Allaf noted that PROSPER's "unique" trial design resulted in 51 patients not receiving neoadjuvant nivolumab, and 45 not undergoing surgery (compared with 28 patients in the observation arm who did not receive surgery).

"This is a trial in the beginning of its analysis cycle, and there are many things we do not yet know," Allaf pointed out. "For example, why did some patients not receive nivolumab? Why did some patients not undergo surgery? What about overall survival? Lots of questions."

Powles noted that this trial "has a number of design and methodology issues," suggesting it "is not possible to judge the comparative activity of nivolumab based on this trial."

IMmotion010

In this study of 778 patients enrolled from January 2017 to February 2019 and randomized 1:1 to atezolizumab or placebo, the 3-year DFS rate was 59.4% in the atezolizumab group and 59.0% in the placebo group.

At data cutoff, OS data were immature. There were 107 deaths, 54 in the atezolizumab group and 53 in the placebo group. There was no evidence of a reduced risk of death from any cause with adjuvant atezolizumab compared with placebo (HR 0.97, 95% CI 0.67-1.42). The 3-year OS rates were 90.3% in the atezolizumab group and 89.8% in the placebo group.

The most common grade 3/4 adverse events were hypertension (2% with atezolizumab vs 4% with placebo), hyperglycemia (3% vs 2%), and diarrhea (1% vs 2%). Serious adverse events occurred in 18% of patients who received atezolizumab and 12% of patients who received placebo.

Powles noted that the IMmotion150 trial showed a response rate of 25% and a complete response rate of 11% with atezolizumab in patients with treatment-naive metastatic RCC. "So, atezolizumab has activity in kidney cancer," he said. "I think it is fair to say that atezolizumab looks less active in this setting."

Disclosures

CheckMate-914 was funded by Bristol Myers Squibb.

Motzer reported relationships with AstraZeneca, Aveo Pharmaceuticals, Bristol Myers Squibb, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly Oncology, Merck, Novartis, and Pfizer.

PROSPER was funded by the National Cancer Institute and the Canadian Cancer Society.

Allaf had no disclosures.

IMmotion010 was funded by F. Hoffmann-La Roche.

Bex reported relationships with Pfizer, Roche/Genentech, Bristol Myers Squibb, the International Kidney Cancer Coalition, and the Kidney Cancer Association.

Powles reported relationships with MSD, Merck Serono, Pfizer, GSK, Novartis, Roche, AstraZeneca, Bristol Myers Squibb, Exelixis, Ipsen, Seagen, Astellas, Janssen, Eisai, Mashup, Genentech, Natera, FMI, and Takeda.

Primary Source

European Society for Medical Oncology

Source Reference: Motzer RJ, et al "Adjuvant nivolumab plus ipilimumab vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from the randomized phase III CheckMate 914 trial" ESMO 2022; Abstract LBA4.

Secondary Source

European Society for Medical Oncology

Source Reference: Allaf ME, et al "Phase III randomized study comparing perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER, ECOG-ACRIN EA8143), a National Clinical Trials Network trial" ESMO 2022; Abstract LBA67.

Additional Source

European Society for Medical Oncology

Source Reference: Bex A, et al "IMmotion010: Efficacy and safety from the phase III study of atezolizumab vs placebo as adjuvant therapy in patients with renal cell carcinoma at increased risk of recurrence after resection" ESMO 2022; Abstract LBA66.

https://www.medpagetoday.com/meetingcoverage/esmo/100660