Latest news with #Opdivo
Time of India
3 days ago
- Business
- Time of India
Zydus Life's plans for cancer biosimilar hit a legal hurdle
Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Mumbai: The Delhi High Court has issued an interim injunction against Ahmedabad-based drug maker Zydus Lifesciences after a case filed by the US pharma giant Bristol Myers Squibb alleging patent infringement on its blockbuster anticancer drug Opdyta nivolumab ) branded as Opdivo in other restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 101-page order issued on July 18 by Justice Mini Pushkarna ruled that the defendants, and all others acting on its behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of nivolumab, the suit patent, during the pendency of the present suit. The order stated the plaintiffs shall suffer irreparable loss, in case the interim relief as prayed for, was not injections are one of the many latest generation immunotherapy drugs also known as checkpoint inhibitors increasingly used to treat several types of cancers including skin, lungs, kidneys, and Hodgkin lymphoma. It works by activating the body's T-cells or immune cells by targeting a protein called PD-1, thereby unleashing an attack on the cancer vials are sold in India for roughly '2 lakh but for patients who are part of the company's assistance or access programs, the drug is available at a slab-wise discounted the India data is not available, globally Bristol Myers Squibb recorded Opdivo sales of $9.3 billion in 2024. Indian companies have launched biosimilars at half the cost of those charged by their global in Indian patent laws told ET that the court has taken a view that stockpiling of a product during its active patent life amounts to infringement and to release it or flood the market is not legally valid."This opinion may have implications for the other ongoing disputes like the weight-loss drug semaglutide (branded Wegovy) case between Novo Nordisk and Dr. Reddy's Labs or Roche versus Natco for Risdiplam (drug used for a rare disease called spinal muscular atrophy or SMA) case," a senior lawyer petition from BMS noted that Zydus Lifesciences was conducting clinical trials for nivolumab and on its investigation found that the company had plans to launch it during the patent period. The Indian company, it said, had applied for a marketing approval with the central drug regulatory its part, lawyers on behalf of Zydus defended saying its product ZRC-3276 does not infringe upon the existing patents and is following the regulatory was represented by a battery of top lawyers including Harish Salve, Dushyant Dave, and Rajiv Nayar, while Squibb & Sons was represented by Sandeep Sethi, PS Raman, Amit Sibal and Pravin Anand, among others.
The Mainichi
15-07-2025
- Health
- The Mainichi
Japan research team discovers new gut bacterium that boosts cancer immunotherapy
TOKYO -- A Japanese research team led by the National Cancer Center Japan announced in the British journal Nature on June 14 that it has discovered a new type of gut bacterium that enhances the effectiveness of cancer immunotherapy drugs, raising hopes for the development of new treatments that further strengthen the immune response against cancer. Cancer immunotherapy leverages the body's immune system to attack cancer cells. One class of drugs, known as immune checkpoint inhibitors -- including PD-1 inhibitors such as Opdivo -- works by releasing the "brakes" that cancer uses to evade immune cell attacks, thereby restoring the immune system's natural ability to target tumors. However, even when used in combination with other treatments, checkpoint inhibitors are effective in only about 20% of patients over the long term. Previous studies have shown that transplanting stool from patients who responded well to these drugs into non-responders can improve outcomes, suggesting that gut bacteria play a key role. Until now, the mechanism by which gut bacteria influence cancers located far from the intestines, such as in the lungs, was not well understood. The research team found that patients who responded well to immunotherapy had high levels of a type of gut bacterium from the Ruminococcaceae family. These patients experienced longer-lasting treatment effects and had more T cells -- immune cells that attack cancer -- present within their tumors. The team identified this bacterium as a new strain, named YB328. In mouse experiments, administering both checkpoint inhibitors and YB328 led to tumor shrinkage, and even when YB328 was given together with stool transplanted from non-responders, the drug's effectiveness improved. Further investigation revealed that YB328 activates dendritic cells -- immune system "commanders" that orchestrate immune responses -- in the gut. These dendritic cells then travel from the intestines to distant tumor sites, where they activate nearby T cells and enhance the immune attack on cancer. Hiroyoshi Nishikawa, head of the Cancer Immunology division at the National Cancer Center Research Institute, commented, "Not only could administering this bacterium to (drug) non-responders improve outcomes, but adding it to responders' treatment regimens may further boost effectiveness."
New York Post
08-07-2025
- Health
- New York Post
Doctors have figured out a way to use herpes to fight untreatable advanced cancer
Herpes has been called 'the gift that keeps on giving' — finally, its presence has come in handy. Roughly two-thirds of the global population has been infected with herpes simplex virus type 1 (HSV-1), which typically causes painful and unsightly blisters around the mouth. University of Southern California researchers have found a way to rebrand this oft-embarrassing sore subject by genetically modifying HSV-1 and administering it to patients with treatment-resistant, advanced skin cancer along with an anti-cancer medication. 4 About 3.8 billion people worldwide have been infected with herpes simplex virus type 1 (HSV-1), which typically causes painful and unsightly blisters around the mouth. – In a recent clinical trial, this one-two punch shrank tumors by at least 30% in around one-third of the 140 participants. Nearly one in six saw their tumors completely disappear. 'These findings are very encouraging because melanoma is the fifth most common cancer for adults, and about half of all advanced melanoma cases cannot be managed with currently available immunotherapy treatments,' said Dr. Gino Kim In, a medical oncologist with Keck Medicine of USC. Advanced melanoma means the skin cancer has spread from its initial location to other parts of the body, such as lymph nodes, the liver or the brain. Immunotherapy to help the immune system attack cancer cells, targeted therapy and radiation therapy are common treatment options. 4 This is a close-up of the herpes virus, which may hold the key in the battle against advanced melanoma. BSIP/Universal Images Group via Getty Images 'The survival rate of untreatable advanced melanoma is only a few years, so this new therapy offers hope to patients who may have run out of options to fight the cancer,' In said. In January, the Food and Drug Administration granted priority review to RP1 (the genetically modified HSV-1) with the anti-cancer medication nivolumab (marketed as Opdivo) for advanced melanoma patients whose cancer had not responded to immunotherapy. Nivolumab blocks a key protein that cancer cells use to evade the immune system, paving the way for the immune system to recognize and attack these cells. The idea is that nivolumab would enhance the effects of RP1, which targets, infects and replicates in tumor cells to destroy them — while sparing healthy tissue. In told The Post that RP1 was developed by knocking out specific genes in HSV-1 so that it no longer causes cold sores. 'Additional genetic modifications were made to the virus to stimulate the immune system to better fight the cancer and to help the virus more efficiently interact with and kill tumor cells,' In said. 4 Nivolumab blocks a key protein that cancer cells use to evade the immune system, paving the way for the immune system to recognize and attack these cells. luchschenF – In the USC trial, researchers injected RP1 into superficial tumors on or near the skin's surface and into tumors deeper in the body, like in the liver or lungs. We're Tracking Prime Day Live! Unlock exclusive NYP codes and real-time deals on everyday must-haves. See Your Deals The combination therapy was administered every two weeks for up to eight cycles. Afterwards, the patients who started to see results took just nivolumab every four weeks for up to two years. Researchers were stunned to notice a difference in the size of the treated and untreated tumors. The untouched tumors shrank or disappeared as often as the injected ones. 'This result suggests that RPI is effective in targeting cancer throughout the entire body and not just the injected tumor,' said In, 'which expands the potential effectiveness of the drug because some tumors may be more difficult or impossible to reach.' 4 Dr. Gino Kim In, a medical oncologist with Keck Medicine of USC, is one of the lead investigators on the trial. Keck Medicine of USC RP1 was reported to be well-tolerated among the participants. Results from the trial were published Tuesday in the Journal of Clinical Oncology and recently presented at the American Society of Clinical Oncology annual meeting. In and his team launched a phase 3 trial to study the effects of this treatment in over 400 cancer patients. People interested in participating in the trial, sponsored by RP1 manufacturer Replimune, should contact Sandy Tran at
Yahoo
08-07-2025
- Business
- Yahoo
Colorectal Cancer Treatment Market Size is Projected to Reach USD 24.77 Billion, with a Robust 3.2% CAGR till 2031, Rising Prevalence of Cancer Boosts
NEW YORK, July 8, 2025 /PRNewswire/ -- According to a new comprehensive report from The Insight Partners, the global colorectal cancer treatment market is observing significant growth owing to the increasing prevalence of cancer and growing demand for rare disease diagnostic tools. The colorectal cancer treatment market is expected to reach US$24.77 billion by 2031 from US$19.93 billion in 2024, at a CAGR of 3.2% during the forecast period. Colorectal cancer, also referred to as colon cancer or bowel cancer, develops in the colon or rectum. The disease is a significant health concern, being the third most common cancer worldwide. The report runs an in-depth analysis of market trends, key players, and future opportunities. The colorectal cancer treatment market comprises a vast array of products and services that are expected to register strength during the forecast period. To explore the valuable insights in the Colorectal Cancer Treatment Market report, you can easily download a sample PDF of the report – Overview of Report Findings Increasing Burden of Colorectal Cancer: According to the World Health Organization (WHO), colon cancer is the second leading cause of cancer-related deaths worldwide. In 2022, there were over 1.9 million new colorectal cancer cases and more than 930,000 deaths due to this disease globally. Incidence rates were highest in Europe, as well as Australia and New Zealand, while mortality rates were highest in Eastern Europe. By 2040, the burden of colorectal cancer is projected to increase to 3.2 million new cases per year—a 63% rise—and to 1.6 million deaths per year, reflecting a 73% increase. The increasing prevalence of colorectal cancer is expected to drive the demand for its treatment in the coming years. Surging Advancements in Treatments and Product Approvals: The advancement and acceptance of sophisticated treatments; such as targeted therapies (e.g., cetuximab, bevacizumab, regorafenib), immunotherapies, and combination therapies; have enhanced patient outcomes and broadened treatment options. Continued research and new product approvals, including biosimilars and personalized medicine, are driving market growth. For instance, in April 2025, the Food and Drug Administration (FDA) approved the combination of two immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), for the initial treatment of some patients with advanced colorectal cancer. This approval expands the use of this immunotherapy combination into the first-line setting and can be used as the initial treatment. Geographical Insights: In 2024, North America led the market with a substantial revenue share, followed by Europe and APAC. Asia Pacific is expected to register the highest CAGR during the forecast period. For Detailed Colorectal Cancer Treatment Market Insights, Visit: Market Segmentation Based on treatment type, the colorectal cancer treatment market is segmented into surgery, chemotherapy, targeted therapy, immunotherapy, and others. In 2024, the surgery segment held the largest colorectal cancer treatment market share and is expected to register the highest CAGR during 2025–2030. By age group, the colorectal cancer treatment market is segmented into below 49 years, 50–64 years, and above 65 years. The above 65 years segment held the largest colorectal cancer treatment market share in 2024. In terms of application, the colorectal cancer treatment market is divided into preclinical drug development, biomarker analysis, translating research, and biobanking. The preclinical drug development segment held the largest share of the colorectal cancer treatment market in 2024. In terms of end user, the colorectal cancer treatment market is segmented into hospitals, specialty clinics, home care, and others. The hospitals segment held the largest share of the colorectal cancer treatment market in 2024. The colorectal cancer treatment market is segmented into five major regions: North America, Europe, APAC, Middle East and Africa, and South and Central America. Stay Updated on The Latest Colorectal Cancer Treatment Market Trends: Competitive Strategy and Development Key Players: A few major companies operating in the colorectal cancer treatment market are Champions Oncology, Inc.; Charles River Laboratories, Inc.; Crown Bioscience, Inc.; EPO Berlin-Buch GmbH; Hera BioLabs; Horizon Discovery Group plc; Oncodesign; Pharmatest Services Ltd; Urolead; and Xentech. Trending Topics: Advanced Colorectal Cancer Treatments, AI in Colorectal Cancer Treatments, Oncology PDX models, and PDX models for research, among others. Global Headlines on Colorectal Cancer Treatment Takeda Pharmaceutical announced the approval for its oral targeted therapy FRUZAQLA (fruquintinib) from the US Food and Drug Administration (FDA) to treat adults having metastatic colorectal cancer (mCRC). FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the US for treating mCRC previously, regardless of biomarker status. Taiho Pharmaceutical Co., Ltd. announced that the US FDA had approved LONSURF (trifluridine/tipiracil) as a single agent and in combination with bevacizumab for treating mCRC patients. These patients are previously treated with oxaliplatin-, fluoropyrimidine-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy. The Food and Drug Administration granted accelerated approval to adagrasib (Krazati) plus cetuximab developed by Mirati Therapeutics, Inc. for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Purchase Premium Copy of Global Colorectal Cancer Treatment Market Size and Growth Report (2021-2031) at: The rising prevalence of colorectal cancer and increasing innovations in cancer therapies drive the colorectal cancer treatment market growth. Colorectal cancer continues to be one of the leading causes of illness and death worldwide, with millions of new cases diagnosed each year. The increasing prevalence of CRC directly correlates with an increased demand for a wide range of treatments such as surgery, chemotherapy, targeted therapies, immunotherapy, and supportive care services. Pharmaceutical and biotech firms are investing significantly in research and development to meet unmet needs, especially for younger patients and those suffering from advanced or resistant diseases. In November 2023, Takeda received the U.S. Food and Drug Administration (FDA) approval for FRUZAQLA (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Additionally, the rise in early-onset cases is encouraging advancements in personalized medicine and less invasive surgical methods. According to an article published in White Rose in December 2024, in England, the use of minimally invasive surgery (MIS) for resections has significantly increased. For colon cancer, the percentage of resections performed using MIS increased from 34.9% in 2007 to 72.9% in 2021, while for rectal cancer it grew from 28.8% to 72.5%. Additionally, robot-assisted surgery for colon cancer increased from 0.1% in 2007 to 2.7% in 2021, and for rectal cancer from 0.2% in 2007 to 7.9% in 2021. However, there was a wide variation in the adoption of MIS at the hospital level between during 2007–2021. The report from The Insight Partners, therefore, provides several stakeholders—including PDX model developers, academic and research organizations, healthcare facilities, and others, with valuable insights to successfully navigate this evolving market landscape and unlock new opportunities. Trending Related Reports: The Kidney Cancer Therapeutics and Diagnostics Market is expected to register a CAGR of 4.9% from 2025 to 2031, The Cervical Cancer Diagnostics and Therapeutics Market is expected to register a CAGR of 4.5% from 2025 to 2031, The Ovarian Cancer Diagnostics and Therapeutics Market is expected to register a CAGR of 9.4% from 2025 to 2031 The Cancer Stem Cells Market is expected to register a CAGR of 19% from 2025 to 2031 The Cancer Therapy Market is expected to register a CAGR of 8.2% from 2025 to 2031 The Cancer Biopsies Market is expected to register a CAGR of 11.6% from 2025 to 2031 The Uterine Cancer Therapeutics & Diagnostics Market is expected to register a CAGR of 5.9% from 2025 to 2031 The Thyroid Cancer Diagnostics Market is expected to register a CAGR of 5.5% from 2025 to 2031 The Skin Cancer Diagnostics and Therapeutics Market is expected to register a CAGR of 5.6% from 2025 to 2031 The liver cancer diagnostics market size is projected to reach US$ 20.57 billion by 2031 The Pancreatic Cancer Therapy Market size is expected to reach US$ 6.47 billion by 2031 About Us: The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials. Contact Us: If you have any queries about this report or if you would like further information, please contact us: Contact Person: Ankit MathurE-mail: +1-646-491-9876Home - Logo: View original content: SOURCE The Insight Partners Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Boston Globe
08-07-2025
- Health
- Boston Globe
A breakthrough in a Harvard lab led to a new cancer drug. Could it save a man with six months to live?
'You'll want to call hospice,' the surgeon told Sehy's wife, Jean, before her husband even woke from anesthesia. At the time, about 70,000 Americans were diagnosed with melanoma every year. When the disease tipped into the advanced stages, it was pretty much a death sentence —only about 5 percent of patients might go into remission. Sehy's doctors estimated he had six months to live, though chemotherapy might stretch that a little longer if he could tolerate the side effects. Advertisement Jean was quiet and numb on the drive back to rural Illinois, mulling over the prognosis. They'd been married 40 years and raised four children. Sehy owned a marketing supply company for veterinarians and the couple had been hoping to travel and spend more time with their two grandchildren. All those dreams were crumbling. At home in the tiny farming and manufacturing town of (pop. 1,587), Sehy held onto a last-ditch suggestion from his oncologist: Sehy mowed his lawn at home in Teutopolis. Kate Munsch for The Boston Globe He began to methodically email every researcher his doctor pointed him toward, though the early responses were disappointing. Some weren't studying his type of cancer, others didn't have any room left in their trials. Finally, after months, one doctor 300 miles away in Nashville said he had an opening in his medical center's drug. It was called Advertisement MDX-1106, later known as Opdivo, would take more than five years of research and testing to become one of the key early successes of immunotherapy, arguably the most important advance in cancer treatment in a generation. Joined by similar drugs such as Keytruda that enlist the body's immune system to fight cancer, it would add years to the lives of millions of patients. Without it, they might only have expected months. The story of Opdivo leads all the way back to President Trump's administration has cut nearly $3 billion in research funding to Harvard, affecting awarded to scores of universities and hospitals by the NIH — a Advertisement The Harvard Medical School complex in Boston. David L. Ryan/Globe Staff Liberal bias has supplanted America's scientific enterprise, the administration said, and the country needs MDX-1106 is the story of what happens when the time-honored paradigm works — and what risks being lost in its disruption. To get to 2009, when Sehy joined the clinical trial, took years of discovery at Harvard and elsewhere, aided by federal funding. It would be years more work before federal regulators deemed the drug safe and effective for patients. Interrupt any step in that process, and cancer patients like Sehy didn't stand a chance. The twisting road of research The public outcry to the biomedical research cuts has been loud but not as fierce as many scientists expected, considering that the federal government has been essential to developing medical treatments. A recent review looked at 356 drugs approved by federal regulators between 2010 and 2019. NIH funding But 'this message is not getting through,' said Dr. Benjamin Miller, chair of the aging and metabolism research program at the Oklahoma Medical Research Foundation. His Oklahoma City-based nonprofit has helped usher three new drugs into the world, among other advances, and is now seeing its federal grants cut. 'For many years as scientists, we just sort of thought that people understood why this money was important,' Miller said, 'and we didn't spend enough time engaging in these conversations to connect those dots for people.' Truly connecting the dots would show that defunding basic research today threatens to block the advances not of tomorrow, but those that might come five or ten or twenty years in the future. Advertisement It's easy to imagine that the process of biomedical research is like building a bridge: Design the blueprint, then simply start connecting beams and bolts until you get to the other side. In reality, though, moving from a breakthrough in a lab to a drug for patients — the journey from bench to bedside, as scientists call it — is more like traveling a road full of twists, turns, and detours. Cholesterol-fighting statins, the most widely prescribed drugs in the world, It took A breakthrough at Harvard Dr. Arlene Sharpe, head of the immunology department at Harvard Medical School, grew up in Gary, Ind. In elementary school, she labored over an experiment on lima bean germination for her science fair. She won a blue ribbon. Sharpe's parents encouraged her curiosity and, as gardeners themselves, were particularly delighted by her interest in hydroponics. 'They let me set up these aquaria in our house; I'd have the chicken wire, and I'd have the plants I was trying to grow,' Sharpe recalled, smiling at the memory. 'All I ever grew then was mold.' In 1969, when Sharpe was 15, her mother died of leukemia. At the time, people only whispered the word 'cancer' and treatment options were limited. That seemed wrong to Sharpe. She thought scientists should be able to do something. Advertisement Sharpe headed to Harvard for college in the early 1970s. There she met Gordon Freeman, a lanky, soft-spoken Texan, and they clicked over a shared passion for the endless possibilities of biology. The two married in 1978, had two children, and eventually began collaborating on research. They focused on the immune system, a complex network of cells and organs that defends the body from disease and infection. With significant financial support from federal research grants, they wanted to better understand what happened when the system faced problems, such as asthma and cancer. Dr. Arlene Sharpe, with her husband and co-investigator Gordon Freeman, at the Sharpe Laboratory at Harvard Medical School. Jonathan Wiggs/Globe Staff In the lab, Sharpe and Freeman offered complementary strengths that combined to make a formidable team. Freeman had a talent for identifying new molecules to explore. Sharpe was adept at removing those molecules from mice, then measuring whether the change strengthened the rodents' immune defenses or weakened them. In 1995 they had a breakthrough. When they deleted a certain molecule on a type of white blood cell called a T cell, they noticed the rodent's immune system shifted into overdrive. Intrigued by the potential of regulating the immune response, Sharpe and her colleagues The next year, Berkeley researcher, showed for the first time that blocking the same molecule, CTLA-4, could eliminate tumors in mice. That flung open the door to a potential new way of treating cancer in humans, by unleashing the immune system to fight the disease. A display of vital molecules in cancer immunotherapy that Sharpe and Freeman co-discovered. Jonathan Wiggs/Globe Staff The race was on to find other molecules that could prime the body to attack tumors. 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Proteins called T cell receptors detect cancer antigens (substances on the surface of cancer cells. ) But the T-cell is unable to attack the cancer because another T cell protein, PD-1, is bound to a protein on the cancer cell, called PD-L1, that's putting the brakes on the immune system. Immunotherapy cancer drugs, anti-PD-1 medicines, release the brakes on the immune system and allow T cells to attack the cancer. SOURCE: Gordon Freeman, and program Biorender. RYAN HUDDLE/GLOBE STAFF and Adobe Shutterstock In a way, PD-L1 tricked the body's defenses into ignoring tumors, allowing them to grow and spread unchecked. Just when the immune system should be speeding ahead to fight cancer, PD-L1 slammed on the brakes. Sharpe and Freeman also took another step, demonstrating how the body could recognize cancer as dangerous and then release the immune system's brakes. They knew it was an important insight. Translating it from the lab setting into a treatment for patients, however, wasn't going to be easy. From bench to bedside Despite the promise of immunotherapy in the early 2000s, many cancer specialists remained skeptical. Chemotherapy was long-studied and widely used, even though using it was like dropping a bomb that obliterated cancer cells and healthy ones alike. Could immunotherapy, which sought to marshal the body's own defenses, really work? 'We thought we were at the vanguard of a whole new approach to treating cancer,' recalled Dr. Israel Lowy, then director of clinical science at Medarex, a small biopharmaceutical company in New Jersey. 'But no one took us seriously.' Lowy had been watching Sharpe and Freeman's breakthroughs closely, as Medarex developed an investigational cancer drug. In 2006, his team filed an application with federal regulators for MDX-1106, inspired by research from several scientists, including Sharpe and Freeman's work blocking the PD-L1 protein. Two years later, at a May 2008 conference, the team proudly With results like that, 'We were like kids in a candy store,' recalled Lowy, now a senior vice president at Regeneron, a biotech company. Cancer specialists weren't skeptical any longer. With approval to expand, researchers eventually launched a bigger clinical trial at 13 medical centers around the country, including three in Boston. This time, 306 cancer patients would receive infusions of the experimental drug every two weeks for nearly two years. One of those patients would be Stephen Sehy. The trials of a cancer patient By the winter of 2009, Sehy was getting sicker. It had been eight months since his diagnosis, but the melanoma tumors on his face and liver had overtaken the cocktail of chemotherapy drugs he'd been receiving. Still, from the beginning, Sehy had been determined to enjoy whatever time he had left. 'He would say to me, 'OK Jeanie, if I have only six months to live, you are not going to be crying around,'' Jean recalled. Sehy's first infusion of MDX-1106 was scheduled for December 21, 2009. When the couple returned from the 300 mile drive to Vanderbilt University Medical Center in Tennessee, Sehy sat down at a computer to type out a Christmas email. 'Have a great holiday, and enjoy each day,' he wrote to friends and family. 'All the little things in life add up to a big deal!' After that first infusion, he and Jean would not have to wait long for a positive sign. At Sehy's next appointment, just two weeks later, a doctor at Vanderbilt confirmed what the couple feared they'd only been imagining: the tumor near his right ear had shrunk by more than a tenth of an inch. They should know that happens sometimes, the doctor gently explained, and then the tumor comes charging back. The couple let themselves quietly start dreaming anyway, about a trip to Hawaii, maybe one to Alaska. They didn't know if Sehy would live long enough. But they could hope. 'Steve didn't want me to write this, because it may get everyone's hopes up, but I thought, so what?' Jean wrote to their loved ones at one point. 'That's what it's about. HOPE, isn't it?' Over time, the tumors on Sehy's face kept shrinking. They waited for him to suffer side effects, but none came. 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Oct. 2000 Harvard Medical School/Dana-Farber Cancer Institute researcher Gordon Freeman and colleagues show how cancer cells disable immune defenses, and how this cell process, known as PD1/PD-L1, could be blocked. Sharpe and Freeman's research is critical in the design of anti-PD-1 immunotherapies for cancer that restore the immune system's ability to spot and destroy tumors. April 2009 Stephen Sehy is given six months to live after a surgeon discovers melanoma has spread to his liver and spine. Dec. 2009 Sehy enrolls in the Phase One clinical trial of MDX1106, an experimental PD-1 antibody for the treatment of cancer, based on the research from Sharpe and Freeman. The treatment would become the cancer drug Opdivo, approved by FDA in 2014. Jan. - Sept. 2010 The first nine months of 2010 were busy for the Sehys; they welcomed four more grandchildren from January through September. Jan. 2011 Stephen and Jean Sehy take a trip to Hawaii. Oct. 2011 Stephen completes the clinical trial of MDX1106. Nov. & Dec. 2011 The Sehys welcome two more grandchildren, a girl and a boy. Dec. 2011 Scans show the tumors on Stephen Sehy's liver and spine are gone. Here, Sehy is pictured in a Christmas card photo. Aug. 2012 Stephen and Jean vacation in Alaska, where they try the Zip line. Jan. 2013 The couple's ninth grandchild, a grandson, is born. June 2014 Their fifth grandson is born. Later that year FDA approves Keytruda, a drug similar to Opdivo, and soon after approves Opdivo. The drugs enter wide circulation. Feb. 2015 Their sixth grandson, the 11th grandchild, is born. June 2016 A 70th birthday party for Stephen with 100 invited friends and family. July 2019 Stephen and Jean celebrate their 50th wedding anniversary with a party, dinner and dancing. July 2024 The couple vacation in Branson, Missouri with all four of their children and 11 grandkids. That December, two years after he was accepted into the MDX-1106 trial, Sehy received an early holiday gift: Two separate scans showed the tumors on his liver and spine were gone. Not slowing in their growth. Not shrinking. Gone. And Sehy wasn't alone. Word was trickling in from other MDX-1106 trial sites that tumors were also disappearing in other patients. The immunotherapy treatment was working. The age of immunotherapy Dr. Douglas Johnson had helped enroll participants in the MDX-1106 trial at Vanderbilt while he was training in oncology. Even then, he knew all about 'the conversation,' the time doctors had to advise melanoma patients to get their affairs in order. But after the arrival of immunotherapy, he said, that conversation 'changed almost overnight.' In 2011,federal regulators approved Yervoy, Three years later, MDX-1106 — the drug based on Sharpe and Freeman's research at Harvard and now named Opdivo — was approved for cancer patients, as was a similar drug called Keytruda. Today, these immunotherapies are used to treat at least 20 types of cancer and have provided additional years of life for millions of patients. (Last year alone, they also generated more than $23 billion in US sales, according to 'I fell in love with taking care of patients with melanoma in large part because of these drugs coming on board,' said Johnson, now an oncology professor at Vanderbilt who leads a melanoma research program. 'It's such a paradigm shift to be able to offer this to patients who previously didn't have many options.' Before immunotherapy drugs, survival rates for people with metastatic skin cancer were often dismal, Johnson said, with maybe up to 5 percent experiencing remission. Today, advanced melanoma patients treated with a combination of immunotherapies can have a 50 percent or higher survival rate. The number can be around 30 percent for people with bladder or lung cancers treated by immunotherapy. Experts now believe immunotherapy may also train the immune system, through its memory T cells, to recognize cancer if it recurs and keep fighting back, even after treatments have ended. 'In some cases, patients can now live for years with a durable response even after they stop therapy, and we never had anything like that before,' said Dr. Arnold Baskies, former chair of the American Cancer Society's National Board of Directors. Sehy pushed grandson Victor, 10, on a swing in his backyard. Kate Munsch for The Boston Globe That's the way it has gone for Sehy. Sixteen years after he was given six months to live, he remains cancer free. Sehy is now 79, with a shock of white hair and a serious pickleball hobby. The only visible mark of his place in immunotherapy history is a patch of discolored skin in front of his right ear, where doctors removed the last of his tumors months after his final MDX-1106 treatment. He and Jean made it on their trip to Alaska and many other places around the world, too. The two young grandchildren he thought of when he first heard his diagnosis are now 17 years old and have been joined by nine others. A portrait of Stephen and Jean Sehy's family above their fireplace includes their four children and 11 grandchildren. Kate Munsch for The Boston Globe 'There was a time I thought I would never see another grandkid,' Sehy said. 'Now, I'm thinking I just want to see one of them graduate college. And then I'll want to see them get married.' In search of new breakthroughs Whenever she sees advertisements for immunotherapy drugs, Arlene Sharpe does a double-take, remembering her early discovery at Harvard. Even more powerful is meeting cancer survivors who, thanks to treatments that followed, have lived years past their doctors' initial expectations. 'People will come up to me at different meetings and thank me, and they'll tell me that they received either Keytruda or Opdivo a decade ago,' she said. 'And every time, it's just chilling.' But Sharpe, now 71, spends most of her time looking forward, not back. Some patients' tumors don't respond to immunotherapy, and others struggle with significant 'We see that there can be success, and now we want to build on the success,' she said. In recent months, she's had to do that work without federal support. The Trump administration has choked off nearly all government funding to Harvard, including for her research and that of 12 other faculty in her department. She's now searching for private funding sources to keep everything afloat. But that's no guarantee, either. 'Private foundations often want to fund things at a later stage, they don't want to fund the discovery work,' she said. 'It's really the fundamental discovery science that [the government] funds.' Dr. Arlene Sharpe at Harvard Medical School. Jonathan Wiggs/Globe Staff Harvard is challenging the federal cuts, though it has already had to lay off staff and institute hiring freezes. The university has also Sharpe knows the road to a scientific breakthrough is long and twisting, but slowing down is out of the question. About 'There's an urgency here,' Sharpe said. 'Patients and their families don't have the time to wait.' Kay Lazar can be reached at
