A bar director in the restaurant business for three decades quit after a customer spat on her mask.
A server seeking stability for his family found a new job as a high school English teacher.
A chef forced to reorient after reaching “life fulfillment” in a luxurious restaurant found an unexpected upside in office work.
These workers left restaurant and bar jobs as the pandemic forced a hard reset across industries, hitting the restaurant business particularly hard.
Mom-and-pop shops that make up a majority of the industry were vulnerable to the extreme instability of COVID-19 shutdowns and re-openings. Restaurants that were able to reopen came under new threats, including rising prices and workers unable or unwilling to come back to work.
Returning workers, from chefs and managers to short-order cooks and waiters, faced the daily dissonance of being hailed by some as part of the “essential” workforce — while being spat on or cursed at by others, overworked and — in many cases — laid off.
In March 2020 alone, restaurants and bars nationally lost 5 million jobs. By the end of 2021, those businesses were still down 1.1 million jobs
More open hospitality jobs than hires
Hiring spiked in summer 2020 as restaurants and hotels began to reopen. Since then, the number of unfilled jobs has surged past new hires.
Jobs in millions
This chart shows how the number of hires spiked in summer 2020 but then decreased as the number of open jobs outpaced the hires made in the hospitality industry.
Hirings
Job openings
June 2020, dining
restrictions begin to lift
June 2020, dining
restrictions begin to lift
April 2020, pandemic
restrictions in full effect
Data represent jobs in the hospitality industry, including hotel and food service. March 2022 numbers are preliminary. Job opening numbers are measured at the end of the month.
Samantha Masunaga
LOS ANGELES TIMES
Recovery is still far off. Restaurants are lagging other businesses and parts of the economy that have bounced back despite the enduring challenge of hiring across the board.
And though some restaurant workers feel more empowered to demand better pay and conditions, and some employers are responding, widespread changes and a clear plan to steer the industry from the wreckage of COVID-19 are yet to emerge, business owners and experts studying the industry said.
“There won’t be one solution that works,” said Bjorn Hanson, an adjunct faculty member at the NYU Tisch Center for Hospitality who led research last summer on the challenges of recruiting workers back into hotel and restaurant jobs. “It will recover, but it will be a longer recovery,” he said of the industry.
More pay, flexible schedules and better options for career advancement could draw people back, Hanson’s research shows. It included interviews with more than 100 hotel and restaurant employers.
To secure these changes, more restaurant employees are organizing and unionizing than in decades. “The policy is actually changing in response to workers,” said Saru Jayaraman, director of UC Berkeley’s Food Labor Research Center and president of One Fair Wage, a group that advocates for employers to pay workers their full minimum wage, plus tips.
“People in our industry are looking for good places to work. They want to work where they know they’ll be treated well, maybe where they’ll learn a little bit more, where they can grow,” said restaurant veteran Dina Samson, who raised the starting pay at Superfine Pizza, a takeout restaurant she co-owns, to $20 an hour, not including tips, from the previous minimum of $18.
She was able to keep workers from leaving, and hire new ones.
The Times interviewed longtime restaurant and bar workers about why they left their jobs during the pandemic and where they have since landed. All sought more flexibility and a less intense work schedule. Some have gravitated back to the industry they vowed to swear off, as many people continue to find their feet in a scrambled labor market.
Here are five personal stories.
‘I never want to go back to being in a restaurant five days a week’
Gaby Mlynarczyk started bartending in the 1980s. She quit during the pandemic, when she said customers became increasingly hostile.
(Eugene Lee)
Gaby Mlynarczyk started her bartending career in the U.K. in the 1980s as an 18-year-old college student looking to make extra money to buy clothes. After she moved to the U.S. in 1993, she continued working in bars and restaurants, first in New York and then L.A.
“There’s an energy of working in a restaurant or a bar — it’s different every single day,” said Mlynarczyk, 55. “It can be a little bit of a grind at times, but you meet such amazing people working in restaurants and bars, and you learn so much about food and beverage.”
Mlynarczyk was working at a cafe-bar in Playa Vista when the pandemic hit, where she said she noticed customers were not tipping.
In the U.K., she said, restaurant workers are paid a “really good hourly wage,” and although you didn’t often get tips, you could make a living. (In 1992, she made about 18 pounds an hour, which comes out to about $23 an hour in today’s U.S. dollars). In the U.S., servers and bartenders are often paid minimum wage, with customer tips supplementing that income, she said.
“A lot of this is probably why many, many staff in Los Angeles quit their jobs because they realized that they were basically being exploited for no money,” Mlynarczyk said.
She made $75,000 in her last job as bar director of a pop-up in 2021, which came out to about $56,000 after taxes, she said. Her final straw came at that bar last summer, when a guest spat on her mask, she said.
Per state regulations, capacity was limited to about 25%. Hotel guests were infuriated they couldn’t get into an event one night, and it got unruly. Without enough security staff, Mlynarczyk had to act as bouncer, busser, bar director and general manager all at once.
“I got home that night, and I was just like, ‘That’s it. I can’t do this anymore,’” she said. “I never want to go back to being in a restaurant five days a week.”
Mlynarczyk now works with a Napa aperitif company as a brand ambassador who trains staff and promotes the product throughout Southern California. She said she loves having a boss who respects her opinions, makes more money now and is eligible for bonuses.
“Kids coming out of college or on summer vacations will take low-paying jobs for no money just so they have a little extra pocket money,” she said. “But there are also people like myself that want to be in this industry as a career ... and would love to be able to afford to live on the salaries we’re given.”
‘It was the wakeup call that my whole life needed to change’
Jesse Martinez took up cycling more seriously during the pandemic, which helped him reorient his career.
(Mel Melcon / Los Angeles Times)
These days, Jesse Martinez’s life revolves around cycling.
Nearly every Friday morning, he bikes through the Santa Monica Mountains. During his work week, he helps customers at Rapha road cycling and apparel store as a retail associate.
It’s a far cry from his previous life. Last June, Martinez lost his job as a beverage manager and assistant general manager when downtown L.A. bar and restaurant Barcito closed.
Martinez, 31, had worked in the restaurant industry since he was a college student in Bloomington, Ind. It was the only business he’d known, other than a brief stint working in public policy in Washington, D.C. He loved socializing with guests and learning about food and beverages.
“It was something I wanted to craft my future around,” said Martinez, an Encino resident. “Before the pandemic, I would have said, ‘Yes, I am fully in the hospitality industry.’”
When the pandemic forced Barcito permanently shut, Martinez had time to reflect. “It was the wakeup call that my whole life needed to change,” he said.
He was one year sober and had started cycling more seriously — two parts of his life that would become increasingly intertwined, and the pandemic offered the right moment.
“Cycling is the process of constantly reinventing yourself and taking a break to pause when it gets a little tough and finding the energy to try to do it again,” he said. “When I became sober, it was like a deep philosophical marriage. I don’t have to do sobriety perfectly, I don’t have to do cycling perfectly.”
He took a part-time job as a retail associate at Rapha’s Santa Monica store, while also working at Pedalers Fork, a restaurant and bike shop in Calabasas. When Rapha offered him a full-time job, he quit the restaurant work.
In June, he’ll celebrate two years of sobriety. “It’s been a re-orientation of perspective,” Martinez said of his career pivot. “It’s something that’s a little more long-term sustainable.”
Everything he loved about the hospitality industry — meeting guests, helping people — has segued nicely to his retail role, he said.
“The more focused I’ve become the past six months, it’s just made it easier for me to know what I want in life and what I want to cut out,” Martinez said.
‘I hope to make effective change from within’
Karen Fu was furloughed after more than a decade in the restaurant and bar industry. She decided to leave for good, but a salaried management role drew her back.
(Genaro Molina / Los Angeles Times)
For 13 ½ years in restaurant and bar jobs, Karen Fu worked many 10- to 12-hour days, in constant “on” mode to manage staff and guests.
She worked the long shifts on her feet through recurring ankle injuries.
When she was furloughed from her bartending job at the start of the pandemic, she got an unexpected moment to rest. Her personal time became something she cherished.
The bar director at her company asked Fu to return to her job as a bartender, twice. She said no.
“It was a tough decision, absolutely, and I acknowledged being lucky enough to receive unemployment compensation at the time, like many others,” said Fu, 38, an Echo Park resident. “But just the idea of putting personal health and welfare at risk when I had already felt that the weight and burden of sacrifice I’ve made in the past from a career in hospitality ... (I) was aware of that.”
She returned to work about a month and a half before outdoor dining was shut down again in November 2020, then declined to come back after that.
She took up volunteer work for the Restaurant Workers Community Foundation advocacy group, where she is now co-chair of the organization’s grant-writing and nonprofit partnerships committee and was voted onto the board of directors.
Fu said she “found that work more viable and productive in terms of giving back to the industry that I do love and enjoy being a part of.” And while it has been gratifying to see more companies raise wages and improve benefits, she said, “I do think we have a ways to go.”
Fu hoped to find a job in nonprofit work but didn’t get traction. Last month, a longtime acquaintance approached her with a job offer to manage bar operations in a Beverly Hills hotel.
It brought Fu back to the industry she thought she was done with. But in this new management position, she has a salaried job — unlike her previous hourly roles — with better pay, a more balanced schedule and health benefits.
“It has felt right, it has felt good, and I hope to make effective change from within,” she said.
‘My job feels like it’s not going to be here tomorrow’
English teacher Schuyler Mastain holds a copy of Maya Angelou’s “I Know Why the Caged Bird Sings” in his classroom at the New Designs Charter School. Mastain quit his job as a server during the pandemic to become a high school teacher.
(Genaro Molina / Los Angeles Times)
Schuyler Mastain, 39, started working as a waiter at famed downtown L.A. restaurant Rossoblu in 2018 as a way to support himself while he pursued a career in acting.
He loved his work and the restaurant’s management team, but after the pandemic hit and he got married, he wanted to “recession-proof” his life. In August, he quit his job and became a high school English teacher, for less pay.
“Restaurants feel volatile,” Mastain said. He remembers thinking: “My job feels like it’s not going to be here tomorrow. I need something where I can provide for a wife and hopefully, children.”
Teaching hasn’t been everything he hoped it would be, either. Mastain is relatively low on the pay scale because he has only four years of experience. He makes about $4,100 a month, compared with the $5,000 a month he made as a server as Rossoblu.
“My mind was thinking, ‘I need to get something I can count on and build on for the future,’” said Mastain as he sat in his car after a day of teaching in January, when half his class was out due to Omicron infections. He said he thought about going back to his server job.
He occasionally takes shifts at Rossoblu on an on-call basis and plans to work there full time during the summer to supplement his family’s income while school is out. In the fall, he’ll be teaching high school drama full time in the Los Angeles Unified School District.
Despite the lower pay, teaching has its perks. Mastain gets to see his family on Thanksgiving and Christmas, holidays that would be inconceivable in the restaurant business. He spends evenings with his wife.
Mastain remembers how customers were initially understanding of the extra responsibilities and delays the pandemic wrought on restaurant servers. But after a while, they expected things to go back to the way they were and weren’t shy about voicing it.
“I really felt like people didn’t see me,” he said. “They just saw the idea of ‘He’s supposed to get me my thing,’ and that was tough.”
‘If the pandemic had never happened, I would still be a part of it’
M.J. Mercado lost his dream job as a chef in 2020. He decided to get a political science degree to learn about public service work.
(Francine Orr / Los Angeles Times)
M.J. Mercado was in his his dream job five years into his career.
He helped open the upscale restaurant Somni, nestled in the SLS Hotel in Beverly Hills, in 2018 alongside a team of fellow chefs. It boasted an extensive tasting menu prepared in front of diners by the chefs, who also served and interacted with guests.
It was Mercado’s “life fulfillment event,” the culmination of years of training. He learned to cook at home, through his parents and television cooking shows, and went on to culinary school and then to work as a prep cook and line cook.
In 2019, Somni was awarded two Michelin stars. The next year, in March 2020, it temporarily shut down, like many restaurants. It closed for good later that summer.
“I was holding out hope that we were going to reopen,” said Mercado, 29. “We lived and breathed it, and to not be around it, it took a part of us away, essentially.”
The abrupt halt to a high-intensity, eight-year career forced Mercado to think about who he was outside of the kitchen. “This would be a good point in time for me to try something else or do something different,” he said he thought at the time.
He zeroed in on service — a desire to help others — and became interested in public policy after seeing how the city of L.A. tried to help service workers during the pandemic, he said. He enrolled at Santa Monica College, where he is taking classes toward a degree in political science.
To make money, he’s also working for a healthcare company that dispatches nurses to elderly patients’ homes. It’s a 9-to-5 job with weekends off — unheard of in his restaurant career — and he has a more stable idea of his income because of his set schedule. At his Michelin-starred job, he made $16 an hour not including overtime, which he often worked.
Mercado has thought about going back into the restaurant business, but as he looks forward, the long and erratic hours give him pause.
“I plan on having kids of my own,” he said. “I want to know that I can see them on the weekends, I can see them at night, I can be there for my family, and I think having an office job, it helps me do that.”
COVID-19 cases have risen in the U.S. to around 100,000 per day, and the real number could be as much as five times that, given many go unreported.
But the situation is far different from the early months of the pandemic. There are now vaccines and booster shots, and new treatments that dramatically cut the risk of the virus. So how much do cases alone still matter?
That question has prompted debate among experts, even as much of America goes on with their lives, despite the recent surge in cases.
How much concern high case numbers alone should prompt is “the trillion-dollar question,” said Bob Wachter, chair of the department of medicine at the University of California-San Francisco.
In the early days of the pandemic, dying of COVID-19 was a concern for him, but now, in an era of vaccines and treatments, “it doesn’t even cross my mind anymore,” he said.
But he noted there are other risks, including long COVID-19: symptoms like fatigue or difficulty concentrating that can linger for months.
“I think long COVID is pretty scary,” he said.
While cases have risen to around 100,000 reported per day, deaths have stayed flat, a testament to the power of vaccines and booster shots in preventing severe illness, as well as the Pfizer treatment pills Paxlovid, which cut the risk of hospitalization or death by around 90 percent.
Hospitalizations have risen, but only modestly, to around 27,000, one of the lowest points of the pandemic, according to a New York Times tracker.
Cases have now been “partially decoupled” from causing hospitalizations and deaths, said Preeti Malani, an infectious disease expert at the University of Michigan, such that hospitals are no longer overwhelmed.
“[Cases are] not without any consequence, but in terms of pressure on the health system, so far we’re not seeing that, which is really what drove all of this,” she said.
The behavior of much of America reflects a lessened concern about the risk of being infected. Restaurants and bars are packed. Many people do not wear masks even on airplanes or on the subway.
An Axios-Ipsos poll in May found just 36 percent of Americans said there was significant risk in returning to their “normal pre-coronavirus life.”
In the Biden administration, health officials are still advising people to wear masks in areas the Centers for Disease Control and Prevention classifies as at “high” risk. But President Biden himself is talking about the virus far less than he did at the start of his administration, and is not making sustained calls for people to wear masks.
White House COVID-19 response coordinator Ashish Jha touted progress in defanging cases on Thursday.
“We see cases rising, nearly 100,000 cases a day, and yet we’re still seeing death numbers that are substantially, about 90 percent lower, than where they were when the president first took office,” he told reporters.
Some experts are pushing back on the deemphasis of case numbers, saying they still matter.
“The bunk that cases are not important is preposterous,” Eric Topol, professor of molecular medicine at Scripps Research, wrote last month. “They are infections that beget more cases, they beget Long Covid, they beget sickness, hospitalizations and deaths. They are also the underpinning of new variants.”
Even if one does not get severely ill oneself, more cases mean more chances for the virus to spread on to someone who is more vulnerable, like the elderly or immunocompromised.
While deaths are way down from their peak earlier in the pandemic, there are still around 300 people dying from the virus every day, a number that would have proved shocking in a pre-COVID-19 world.
Leana Wen, a public health professor at George Washington University, recommended that people take a rapid test before visiting a more vulnerable person, as a safeguard that avoids more burdensome restrictions.
“Cases alone do not tell the whole story,” she said, adding, “As a policy matter we need to stop using the same comparisons we were in 2020 and 2021.”
There is still much that is unknown about long COVID-19, one of the biggest risks remaining for healthy, younger people who are vaccinated.
A recent article in the Journal of the American Medical Association estimated 10 percent to 30 percent of COVID-19 infections result in long COVID-19 symptoms, but there is no precise estimate.
Experts also urge people who have not gotten their booster shots, or not been vaccinated at all, to do so, given that many are more vulnerable to the virus if they are not up-to-date on their shots.
A new variant also always holds the risk of upending the current risk-benefit calculations. The virus has continued to evolve to spread more easily, and a future mutation could cause more severe illness or more greatly evade vaccines.
Pfizer and Moderna are working on updated vaccines to better target the omicron variant, but the Biden administration warns it will not have enough money to purchase those new vaccines for all Americans this fall unless Congress provides more funding. The funding request has been stalled for months, though, itself a sign of the reduced sense of urgency around the virus fight.
At least for now, though, while many people are getting COVID-19, fewer are getting extremely sick.
“It’s a very risky time if you don’t want to get COVID [at all],” Wachter said. “But a relatively less risky time if your goal is to not get severe COVID or die.”
Curis, Inc. announced the presentation of encouraging clinical data from both the TakeAim Lymphoma and TakeAim Leukemia studies at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting currently taking place in Chicago and online until June 7, 2022. The TakeAim Lymphoma study is a Phase 1/2 open-label, dose escalation, dose expansion clinical trial investigating emavusertib as monotherapy and in combination with ibrutinib in patients with R/R hematologic malignancies, such as non-Hodgkins's lymphoma and other B cell malignancies. The poster presentation (#7575) made by Dr. Grzegorz Nowakowski, Division of Hematology, Mayo Clinic-Minnesota, at ASCO includes clinical data from a May 6, 2022 data cutoff, on 13 patients who received the combination, 9 of whom had post-baseline response assessments and were evaluable for response. Key findings in patients treated with the combination included: The combination appeared to be well tolerated No dose-limiting toxicities (DLTs) at 200mg of emavusertib; 2 DLTs observed at 300mg (stomatitis and syncope) 8 of 9 evaluable patients experienced reduction in tumor burden, including: 2 complete responses (CR) (primary CNS lymphoma and mantle cell lymphoma) 2 partial responses (PR) (chronic lymphocytic leukemia and mantle cell lymphoma) One of the CRs was in a patient who had received prior treatment with ibrutinib, suggesting that the combination may be able to overcome ibrutinib resistance Next steps for the TakeAim Lymphoma study include further dose expansion in order to determine the Recommended Phase 2 Dose for the combination. Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutation such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.
Legend Biotech Corporation presented new and updated results from the CARTITUDE clinical development program studying ciltacabtagene autoleucel (cilta-cel) in the treatment of multiple myeloma at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Earlier data from the CARTITUDE-1 study supported recent regulatory approvals for CARVYKTI™ by the U.S. Food and Drug Administration and the European Commission, and ongoing results from the multi-cohort CARTITUDE-2 study are being used to inform future trials of CARVYKTI™ treatment in multiple patient populations and treatment settings. Data from the ongoing Phase 1b/2 CARTITUDE-1 study continue to show deep and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma at a median 28-month follow up (MFU), with an overall response rate (ORR) of 98% (95% Confident Interval [CI], 92.7-99.7). Responses in 97 patients treated with CARVYKTI™ were sustained from the 22-month median follow-up data previously presented at the 2021 American Society of Hematology (ASH) Annual Meeting, with 83% of patients achieving a stringent complete response (sCR) at median 28 MFU.1 Median progression-free survival (PFS) and median overall survival (OS) were not reached at time of follow-up, suggesting long-term durability of responses and survival for patients. Two-year PFS and OS rates were 55% (95% CI, 44.0–64.6) and 70% (95% CI, 60.1–78.6), respectively. Sixty-one patients had samples evaluable for minimal residual disease (MRD) status, and of those, 92% achieved MRD negativity at the 10-5 threshold.1 Of those evaluable, MRD negativity was sustained for more than 6 months in 68% and more than 12 months in 55% of patients.1 Two year PFS rates in patients who achieved sustained MRD negativity for 6 months or longer and 12 months or longer were 73% (95% CI, 52.1 to 85.9) and 79% (95% CI, 51.5 to 91.8), respectively. In these same patients, two-year OS rates were 94% (95% CI, 76.1 to 98.3) and 91% (95% CI, 67.7 to 97.6), respectively. The CARTITUDE-1 study included patients who received a median of six prior treatment regimens (range, 3-18). All patients were triple-class [immunomodulatory agent (IMiD), proteasome inhibitor (PI) and anti-CD38 antibody] exposed, while 42% of patients were penta-drug refractory and 99% of patients were refractory to the last line of therapy. Median time to first response was one month (range, 0.9-10.7 months), with responses deepening over time.1 Additionally, median time to best response was 2.6 months (range, 0.9-17.8 months) and median time to complete response (CR) or better was 2.9 months (range, 0.9-17.8 months). At 28-month median follow up, the most common hematologic adverse events (AEs) observed were neutropenia (96%); anemia (81%); thrombocytopenia (79%); leukopenia (62%); and lymphopenia (54%). Since the primary 12-month publication, no new events of CRS (no changes in incidence, time to onset, or duration) occurred and one new case of Parkinsonism (also referred to as movement and neurocognitive treatment-emergent adverse events) occurred. Results from the multicohort Phase 2 CARTITUDE-2 study (NCT04133636) evaluating cilta-cel safety and efficacy in various clinical settings for patients with multiple myeloma were also presented at ASCO 2022, demonstrating the promise of CARVYKTI™ earlier in the course of multiple myeloma treatment. Updated data from Cohort A examined the safety and efficacy of cilta-cel in 20 patients with multiple myeloma after one to three prior lines of therapy and who are lenalidomide-refractory (Abstract #8020). At a median follow-up of 17.1 months, the ORR was 95%, which included 90% of patients achieving CR or better and 95% achieving very good partial response (VGPR) or better. The median time to first response was one month and the median time to best response was 2.6 months. The 15-month PFS rate was 70%. Of the 16 patients who were MRD-evaluable, all achieved MRD negativity at 10-5.4 Results from Cohort B of the study, evaluating the safety and efficacy of cilta-cel in patients relapsed or refractory multiple myeloma who received one prior line of therapy including a PI and IMiD and had disease progression within 12 months of treatment with autologous stem cell transplant (ASCT) or within 12 months of the start of antimyeloma therapy for patients who have not had ASCT, were also presented (Abstract #8029). At a median of 13 months follow-up, 19 patients treated in this cohort achieved an ORR of 100%, with 90% of patients achieving a CR or better, and 95% of patients achieving a VGPR or better. Median time to first response was one month (range, 0.9-9.7) and median time to best response was 5.1 months.5 The 12-month PFS rate was 90%. Of the 15 patients who were MRD-evaluable, 14 achieved MRD negativity at 10-5.
Puma Biotechnology, Inc. presented final results from the Phase II SUMMIT ‘basket' trial, assessing the efficacy of neratinib in treatment-refractory patients with metastatic biliary tract cancers with somatic HER2 mutations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation entitled “Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT ‘basket' trial” was presented at the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Poster Session (#4079) by James J. Harding, MD, Regional Director, Early Drug Development, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, an investigator of the trial. Neratinib is an irreversible, pan-HER, oral tyrosine kinase inhibitor. The Phase II SUMMIT trial is an open-label, single-arm, multi-cohort, ‘basket' trial of neratinib in patients with solid tumors that harbor oncogenic somatic HER2 mutations. The study included a cohort of treatment-refractory patients with metastatic biliary tract cancers (BTCs). While HER2 overexpression is associated with an increased risk of disease recurrence in patients with resected BTC, there is limited data on targeting HER2 mutationsin these patients. Efficacy results from the BTC cohort of 25 patients (11 cholangiocarcinoma, 10 gallbladder, 4 ampullary cancers) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months. The most common HER2 mutation was S310F. Co-occurring oncogenic alterations in TP53 and CDKN2A appeared to associate with worse outcome. The most frequently observed toxicity was diarrhea (56% any grade).
Data reported at the 2022 Annual Meeting of the American Society for Clinical Oncology
NBTXR3 is being developed as a product candidate with potential to integrate across the standards of care in oncology, and these data from collaborator-sponsored phase 1b/2 studies add support for the radioenhancer in combination with chemoradiation and in the preoperative setting
Data from the phase 1b/2 head and neck cancer study in 12 evaluable patients with stage 4 disease showed that combining NBTXR3 with concurrent chemoradiation was feasible, had a favorable safety profile, produced a 100% disease control rate, and an overall response rate of 58.3%
Data from the phase 1b/2 rectal cancer study in 31 evaluable patients with unresectable disease showed that combining NBTXR3 with concurrent chemoradiation in the preoperative setting was feasible, had a favorable safety profile, enabled 96% of evaluable patients to undergo R0 surgery, produced a 100% disease-control rate, a 35.5% overall response rate, and a 20% pathological complete response rate in 25 patients who underwent surgery
34% overall response rate in 79 evaluable patients with measurable disease
9.1 months median duration of response
Tumor reduction in 70% of patients
Zeno observed to be very well-tolerated
Potential new standard of care for patients with NRG1+ cancer
Investor call to discuss clinical results on Sunday, June 5 at 6:00 p.m. CT
Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced interim efficacy data as of anApril 12, 2022data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody Zeno in patients with NRG1+ cancer presented virtually by Lead Author, Dr.Alison SchramofMemorial Sloan Kettering Cancer Center(MSKCC) at the 2022 ASCO Annual meeting.
“We have made significant progress with enrollment in the eNRGy trial over the past year,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “And Zeno continues to demonstrate consistent efficacy in patients with multiple types of NRG1+ cancer. We believe Zeno has the potential to be both first in class and best in class as a tumor agnostic treatment for patients with NRG1+ cancer.”
Dr. Schram added, “Zeno has led to durable responses in previously treated NRG1 fusion-positive cancer, with a median duration of response greater than 9 months and more than 25% of those responding continuing at 12 months. Additionally, Zeno has an extremely well tolerated safety profile. There are currently no approved therapies targeting NRG1 fusion-positive cancer and Zeno offers an important, potential new standard of care.”
The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
Date: Sunday, June 5, 6:00 p.m. CT Webcast link: available on our website Dial-in: Toll-free: 18772601463/ International: 17066435907 Conference ID: 7194538