Association between radiotherapy and prognosis in patients with small cell carcinoma of the bladder undergoing bladder-sparing surgery
First Patient With Small Cell Lung Cancer Dosed With Peluntamig
The first patient with small cell lung cancer has been dosed in a trial of peluntamig (PT217) combined with chemotherapy.
Phanes Therapeutics announces the first patient with small cell lung cancer dosed in a trial of peluntamig combined with chemotherapy in the SKYBRIDGE study.
The first patient has been dosed in the clinical trial of peluntamig (PT217) in combination with chemotherapy, according to the drug's manufacturer, Phanes Therapeutics. The drug is being developed for the treatment of small cell lung cancer and neuroendocrine carcinoma, including neuroendocrine prostate cancer.
The multi-center, first-in-human, open-label, phase 2/3 SKYBRIDGE study is investigating the safety, tolerability, pharmacokinetics and initial efficacy of peluntamig in patients with advanced or refractory cancers expressing DLL3. Additionally, a phase 1 trial of peluntamig is being conducted in China. The study plans to enroll and estimated 203 patients as submitted in 2024.
Furthermore, as per the release, peluntamig received two orphan drug designations from the Food and Drug Administration (FDA) for small cell lung cancer and neuroendocrine carcinoma. The agency also granted two fast track designations for extensive-stage small cell lung cancer following platinum chemotherapy with or without a checkpoint inhibitor and for metastatic de novo or treatment-emergent neuroendocrine prostate cancer. Last year, Phanes entered a clinical supply agreement with Roche to evaluate peluntamig in combination with the anti-PD-L1 therapy Tecentriq (atezolizumab).
Glossary:Dose-limiting toxicities: side effects of a treatment that prevent further administration of the drug at the prescribed dose.
Pharmacokinetics: the study of how a drug is absorbed, distributed, metabolized and excreted in the body.
Disease control rate: patients whose disease has stabilized, shrunk or not progressed after treatment.
Measurable disease by RECIST v1.1: a clinical criteria used to assess the size of tumors to evaluate disease progression or response to treatment.
ECOG performance status of 0 or 1: a scale used to assess a patient's level of functioning, with 0 indicating fully active and 1 indicating restricted in physically strenuous activity.
Concurrent malignancy: the presence of more than one cancer in a patient at the same time.
Orphan drug designation is granted by the FDA to drugs or biological products intended to prevent, diagnose or treat rare diseases, providing incentives like tax credits, user fee exemptions and potential market exclusivity, as per the FDA.
The FDA also defines fast track designation as the process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Small cell lung cancer is an aggressive, fast-growing cancer that begins in the lung tissues and can spread to other parts of the body, as per the National Cancer Institute's website. The cancer cells appear small and oval-shaped under a microscope.
The website also defines the bispecific antibody peluntamig which targets DLL3 and CD47 to help the immune system attack cancer cells. By blocking CD47, it allows the body's immune cells to recognize and destroy tumors.
Patients with measurable disease by RECIST v1.1, an ECOG performance status of 0 or 1, adequate organ function, resolved side effects from prior therapies and a life expectancy of at least three months are eligible for the SKYBRIDGE trial. Those who are pregnant or lactating, have autoimmune disease, a concurrent malignancy or uncontrolled hypertension are excluded.
The study includes dose-escalation and dose-expansion phases. The dose-escalation phase determines the recommended phase 2 dose (RP2D), while the dose-expansion phase evaluates two cohorts: one receiving the RP2D and another at a lower dose level.
Primary end goals will assess dose-limiting toxicities, the maximum tolerated dose, the RP2D and safety. Secondary end goals will measure preliminary efficacy and pharmacokinetics, with disease control rate as an exploratory end goal.
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Surviving Life-Threatening Lung Cancer: Lessons Learned
Life-threatening lung cancer has taught me many valuable lessons and made my new normal so fulfilling.
Sue McCarthy received diagnoses of breast cancer in 2001 and lung cancer in 2018. Catch up on all of Sue's blogs here!
My life has changed dramatically since my journey through stage 3B non-small cell lung cancer. I've learned, grown and lived my life more fully than I would ever have thought possible before the experience.
Living One Day at a TimeI can, and now do, live life "one day at a time" as often as possible. Our lives are precious and limited. Certainly, not every day am I blessed with sunshine, blue skies and spring flowers. There are days when I'm privileged to spend the afternoon with my best friend or hug my grandchild. However, every day provides me with something to be grateful for, something new to learn or teach to another.
Making Something Special of My Second Chance at LifeI want, and sometimes even feel the need, to make my second chance at life something special. Facing life-threatening cancer caused me to lose hope on several occasions. And yet, as I recovered spiritually at least twice, I knew that I could rise above so many, if not all, of life's greatest challenges. In addition to not letting fear dominate me when life was difficult, I began to take on and even master situations that would have been overwhelming to me in the past.
Keeping My Body HealthyI respect my body far more than I did before my diagnosis. Although I'm still striving for a better-balanced diet, I've come a long way. Although I liked to exercise in the past, I've moved on to the next level. Throughout my adult life, I've walked and occasionally hiked for pleasure and fitness. I now use my treadmill faithfully in inclement weather and walk outside when the weather is nice. More significantly, I've added more exercises. Alternate days, I lift weights, and once a week, I use a rowing machine as well as a stationary bicycle at the gym. I keep a regular bedtime, and most nights, I sleep seven hours. If I have a difficult night, I take a 20-to-30-minute nap.
Prioritizing FamilyRealizing now the value of family members, both blood relatives and individuals who are so close to me that we've informally "adopted one another," I am now making every attempt to maintain good relationships with all of them. Soon after reaching the five-year mark since my lung cancer diagnosis, I took on the role of cancer support person to cousins on both my mother's and father's sides of our family. I had not had a connection with either of them since we were children, so we were just getting to know each other as we started to share our cancer stories. It was challenging, but also rewarding.
Rising Above Serious ChallengesI now understand that I can become very ill, very weak, feel hopeless emotionally, or a financial failure, and yet climb back out of that hole, attaining comparative health and wealth. It took me one ominous physically, mentally, emotionally and spiritually overwhelming night during chemotherapy treatment to lead me to the realization that I can't and won't give up on myself and even life itself.
Practicing a Dynamic FaithI've learned that God's power in my life is limitless. Going forward, I will never forget that my life is a miracle. I will never minimize God's strength and his capacity to heal me and so many others who turn to Him in their hour of need. I changed churches, which led me to feel more fulfilled in my worship experience. I have become more actively involved as a volunteer in the cancer support group there.
Accepting That My Body Has Undergone Harsh TreatmentMy body has suffered damage as a result of chemotherapy and radiation that has likely weakened it. Yes, it is disappointing that I will probably struggle more with other illnesses; my life expectancy could be shortened. However, there is so much more to be grateful for in my new normal life.
Am I Really Cured?It's hard for any patient with cancer to forget the day he or she was told, "I can treat you, but I can't promise you that you can be cured." Hence, anxiety about recurrence is typically in the back of my mind. Because of this, I prefer the term "remission" to "cure."
And for me, the most important lesson I learned as a result of stage 3B non-small cell lung cancer was that it takes a long time to recover from life-threatening cancer and the treatment necessary to be cured. I had always been a very active person; I wanted and unwisely believed that I would finish treatment and get right back into my old life. I was very wrong, and now I know how important it is to walk, not run, out of treatment and into rest and recovery, then slowly evolve. In my new normal, I am wiser and more content. I am grateful to have become the person I was always meant to be.
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