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Some immunotherapy drugs target the PD-L1 protein, though this expert says that it is still an imperfect biomarker.

PD-L1: An Important, But Imperfect Biomarker

Among patients with advanced castration-sensitive prostate cancer, health-related quality of life was not statistically different between those receiving Erleada (apalutamide) alone or in combination with Zytiga (abiraterone acetate) and prednisone compared with those receiving androgen-deprivation therapy (ADT) plus Zytiga and prednisone, according to findings in 

Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire and its subscales. The questionnaire was completed at baseline and every four weeks until week 25. FACT-P scores range from 0 to 156, with higher scores indicating better quality of life, according to study authors.

There were no significant differences in baseline mean FACT-P total scores or subscales across the three treatment groups: ADT plus Zytiga and prednisone, 118.5; Erleada, 116.1; and Zytiga and prednisone plus Erleada, 114.9.

Health-related quality of life was maintained during the treatment period, with no statistically significant differences at 25 weeks in mean FACT-P total scores or subscales: ADT plus Zytiga and prednisone, 122.3; Erleada monotherapy, 119.5; and Zytiga and prednisone plus Erleada, 119.9.

The Erleada monotherapy and Zytiga and prednisone plus Erleada groups did not experience meaningful improvements in health-related quality of life compared with the ADT plus Zytiga and prednisone group, except in time to deterioration of the emotional well-being score. This outcome was more favorable in those who received Erleada alone, with a 63% reduction in risk compared with the ADT plus Zytiga and prednisone group, which had a 44% reduction in risk.

A prostate-specific antigen level of 0.2 nanograms per milliliter or lower at week 25 was observed in 31 of 41 patients (75.6%) in the ADT plus Zytiga and prednisone group, 24 of 40 patients (60%) in the Erleada monotherapy group and 31 of 39 patients (79.5%) in the Erleada plus Zytiga and prednisone group. The two-year overall survival rates were 92.5% for the ADT plus Zytiga and prednisone group, 87.9% for the Erleada monotherapy group and 92.7% for the Erleada plus Zytiga and prednisone arm.

Treatment-related side effects of any grade were reported in 30 of 42 patients (71.4%) in the ADT plus Zytiga and prednisone group, 34 of 42 patients (81%) in the Erleada monotherapy group and 36 of 44 patients (81.8%) in the Erleada plus Zytiga and prednisone group.

Grade 3 (severe) and 4 (life-threatening) treatment-related side effects occurred in eight of 42 patients (19%) in the ADT plus Zytiga and prednisone group, seven of 42 patients (16.7%) in the Erleada monotherapy group and 10 of 44 patients (22.7%) in the Erleada plus Zytiga and prednisone group. Lower rates of hot flashes and hypertension were reported in patients who received Erleada monotherapy.

Gynecomastia affected 23 of 42 patients (54.8%), and breast pain was reported by six of 42 patients (14.3%) in the Erleada monotherapy group, both higher than rates observed in the other two groups. No new safety signals were detected in
the study.

“Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial” by Dr. Diogo Assed Bastos et al., 

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In patients with advanced castration-sensitive prostate cancer, health-related quality of life (HRQOL) was similar across treatment groups receiving Erleada (apalutamide) alone, APA plus Zytiga (abiraterone acetate) and Deltasone (prednisone), or ADT plus AAP. The study, published in JAMA Network Open, found no significant differences in HRQOL scores at 25 weeks. However, the APA-alone group showed a more favorable time to deterioration in emotional well-being. PSA levels and overall survival rates were comparable, with varying side effect profiles across treatment groups.

A study found no significant HRQOL differences between Erleada-based therapies and ADT plus AAP for advanced castration-sensitive prostate cancer.

Tumor

Erleada Combo Shows Comparable Quality of Life Outcomes in Prostate Cancer

In a real-world setting, standard-of-care Carvykti (ciltacabta-gene autoleucel) has been shown to elicit responses from nearly all participating patients with relapsed/ refractory multiple myeloma (R/R MM).

Carvykti is a type of chimeric antigen receptor-T (CAR-T ) cell therapy, which, as explained by the National Cancer Institute, involves a patient’s T cells — part
of the immune system — being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient.

Overall and complete response rates were 89% and 70%, respectively, in
all patients who received Carvykti, 94% and 74% in 191 patients who received conforming Carvykti and 95% and 76% in 152 patients treated with conforming Carvykti with fludarabine/ cyclophosphamide lymphodepletion.

A comforming treatment is administered according to the specifications of
the FDA’s approval, and lymphodepletion is a short course of chemotherapy administered before CAR-T cell therapy.

 for adults with R/R MM who had received at least four prior lines of treatment. In 2024, the agency approved Carvykti for patients who received at least one prior line of therapy.

, that led to the FDA’s 2022 approval of Carvykti, the overall response rate was 98%, with 83% stringent complete response, according to findings published in 2023.

Patients with R/R MM who underwent leukapheresis, or the collection of healthy white blood cells from a patient, for Carvykti manufacturing at 16 American academic medical centers were included in the study, published in Blood, with 255 patients undergoing leukapheresis and 236 receiving Carvykti.

Of the real-world patients, 54% would not have met the eligibility criteria for CARTITUDE-1.

Senior author Dr. Doris K. Hansen of Moffitt Cancer Center’s Department
of Blood and Marrow Transplant and Cellular Immunotherapy, explained in an interview with 

 why such real-world findings are significant.

“Clinical trials are invaluable because they serve as the gold standard for introducing new therapies and advancing science,” Hansen explained.

“However, clinical trials often have strict eligibility criteria. Patients must meet very specific criteria to participate — they need to have good organ function, stable blood counts and no significant comorbidities."

In contrast, Hansen said, the patients seen in day-to-day clinical practice often have a variety of health challenges, with many patients having comorbid conditions like cardiac issues or renal impairment, and with about 20% of those diagnosed with myeloma experiencing kidney problems. “Additionally,” Hansen said, “some patients may have plasma cell leukemia, amyloidosis or myeloma-related bone damage, which can lead to fractures, pain and even reduced mobility or wheelchair use. These factors often make patients ineligible for clinical trials. ... It is, therefore, very important to report on the experiences of these patients. By studying their outcomes, we can understand how treatments perform in real-world scenarios, as opposed to the controlled, ideal conditions of clinical trials.”

The eligibility criteria for CARTITUDE-1 included adequate organ function, limited comorbidities and having no prior exposure to B-cell maturation antigentargeted therapy.

Cytokine release syndrome was experienced by 75% of patients, with grade 3 (severe) or higher in 5%. Immune effector cell-associated neurotoxicity syndrome was seen in 14%, with grade 3 or higher in 4%. Delayed neurotoxicity was reported in 10% of patients.

Researchers reported a 10% nonrelapse mortality rate, mostly from infections, and noted that second primary malignancies, excluding nonmelanoma skin cancers, were seen in 5.5% of patients and myeloid malignancies/acute leukemia in 1.7%.

 such as Carvykti, as explained by the National Cancer Institute, involves a patient’s T cells, part of the immune system, being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient. Carvykti is currently approved by the FDA to be administered in the second line of treatment.

Safety and Efficacy of Standard of Care Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma” by Dr. Surbhi Sidana, et al., 

Carvykti (ciltacabtagene autoleucel) demonstrates significant efficacy in real-world settings for relapsed or refractory multiple myeloma, with 89% of patients responding and 70% achieving complete response. Despite many patients not meeting clinical trial criteria, outcomes were comparable to the CARTITUDE-1 trial. At 13 months, median progression-free survival and overall survival were not reached, with 12-month estimates at 68% and 82%, respectively. Side effects included cytokine release syndrome and neurotoxicity. Carvykti, a CAR-T cell therapy, is FDA-approved for patients with multiple prior treatments.

The CAR-T cell therapy Carvykti has been shown to be effective among patients outside the confines of a clinical trial.

Carvykti Effective in Real-World Setting for Myeloma 

Among patients with stage 3 unresectable non-small cell lung cancer (NSCLC), the first participant has been dosed in the phase 2 CONVERGE study, according to a news release from biotechnology company Nanobiotix. The randomized, controlled clinical trial is evaluating the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) in patients being treated with standard-of-care chemoradiation followed by consolidation Imfinzi (durvalumab).

“We believe the true value of [NBTXR3] is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in [non-small cell lung cancer] NSCLC brings us another step closer to delivering for the large number of patients [NBTXR3] is designed to serve.”

Who is Eligible For CONVERGE Study Enrollment?

According to the clinical trial page
at clinicaltrials.gov, CONVERGE is evaluating the addition of NBTXR3 to concurrent platinum-based doublet chemotherapy with radiation therapy, followed by consolidation immunotherapy, and whether this enhances the objective response rate in patients with locally advanced, unresectable stage 3 NSCLC.

To be considered eligible for enrollment, patients must be candidates for chemotherapy with radiation therapy; have a pathologically confirmed NSCLC diagnosis within three months prior to enrollment; present with unresectable stage 3IIIA or 3IIIB NSCLC; have at least one target lesion suitable for intratumoral or /intranodal injection and external beam radiation therapy; and have an ECOG performance status of 0 or 1.

Participants are considered ineligible for enrollment in the study if they have a history of primary immunodeficiency; organ transplantation requiring immunosuppression; significant cardiac events within three months before enrollment; concurrent or recent malignancies other than NSCLC; and known hypersensitivity to study drugs or components.

Patients with active bleeding diathesis or patients requiring anticoagulation or antiplatelet therapy that cannot be safely modified for procedures are also excluded.

The novel, potentially first-in-class oncology product NBTXR3 comprises functionalized hafnium oxide crystal nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The proof-of-concept for NBTXR3 was demonstrated in soft tissue sarcomas, leading to the agent receiving a European CE mark in 2019.

The agent’s mechanism of action is designed to induce substantial tumor cell death within the injected tumor when activated by radiotherapy, thereby triggering an adaptive immune response and establishing long-term anticancer memory. Consequently, the company anticipates that NBTXR3 could be applied to any solid tumor treatable with radiotherapy and be adaptable to any therapeutic combination, especially with immune checkpoint inhibitors.

The radiotherapy-activated NBTXR3 is under evaluation for multiple solid tumor indications as a stand-alone treatment and in combination with anti-PD-1 immune checkpoint inhibitors. These initiatives include the global, randomized NANORAY-312 trial, which is focused on locally advanced head and neck squamous cell carcinomas. In February 2020, the Food and Drug Administration granted fast track designation to NBTXR3 activated by radiotherapy, with or without Erbitux (cetuximab), for patients with locally advanced head and neck squamous cell carcinoma who are ineligible for platinum-based chemotherapy.

In 2019, the company entered a comprehensive clinical research partnership with The University of Texas MD Anderson Cancer Center to sponsor multiple phase 1 and 2 trials evaluating NBTXR3 across various tumor types and therapeutic combinations. Nanobiotix announced a license agreement with Janssen Pharmaceuticals, a Johnson & Johnson company, for the global co-development and commercialization of NBTXR3 in 2023.

The phase 2 CONVERGE study has commenced dosing its first participant to evaluate the radioenhancer JNJ-1900 (NBTXR3) in stage III unresectable non-small cell lung cancer (NSCLC) patients. This trial investigates the efficacy of NBTXR3 combined with standard chemoradiation and consolidation durvalumab. NBTXR3, a hafnium oxide nanoparticle, is activated by radiotherapy to induce tumor cell death and an adaptive immune response. The study aims to enhance objective response rates in NSCLC, with eligibility criteria including specific NSCLC stages and performance status, while excluding certain medical conditions.

The first participant has been dosed on the phase 2 CONVERGE study evaluating NBTXR3 in stage III, unresectable non–small cell lung cancer.

Breaking Down the CONVERGE Study of NBTXR3 in Stage 3 Unresectable NSCLC

The woman who raised me and I did not always see eye to eye. In fact, as two stubborn, opinionated characters we frequently bickered, challenged and exchanged choice words with one another. 

As I reflect on 25 years strong with Mom, here are some of my favorite words that we exchanged. We gave each other many cards over the past few years, one of which she had told me she looked for a long time searching for the right message to express her feelings. It reads:

"When you have a daughter who makes you proud, makes you laugh and, very often, makes your day ... you know what joy is. When you have a daughter who is a good person with a gracious heart and generous spirit ... you know what peace is. When you have a daughter whose beauty (inside and out) is matched only by her compassion for others ... you know what love is. Because I have you for my daughter, I know what it is to be truly blessed."

When I first read those words — as I read them now — I feel so close to my mom. Recently, I found a card with the words that expressed how I feel about her. I read this aloud to her on Christmas Day.

"Dear Mom, I'm so grateful for the way I was raised. You were never afraid to be my mother — to put your foot down, to teach me right from wrong, to make sure I did my best. You always let me know I had a mama who cared about me, who believed in me, who was there for me no matter what. Growing up with that kind of love and support made such a difference in my life; it made me who I am today."

My mother was never afraid to voice her opinion or be one to mince words, to put it lightly; but she was always pure in her intentions and true in her actions, and I feel so clearly, so humbly loved. As I go forward, I remember her strength and purity, her fierce sense of pride, her generous heart and sensitivity, her sense of humor (she once packed me a peanut-butter-jelly-and-ham sandwich because I refused to pick one of the two). 

Throughout her life and especially in her fight against lung cancer, Mom set us an example in unconditional devotion, taught our family valuable life lessons and never lost her indomitable spirit.

I know Mom is with us now and always. Goodbyes are only for those who love with their eyes, because for those who love with heart and soul there is no such thing as separation. I love you Mom, Happy New Year. Rest in peace and God bless.

For more news on cancer updates, research and education, don’t forget to

The narrative reflects on a complex yet deeply loving relationship between a daughter and her mother, characterized by mutual respect and understanding despite frequent disagreements. The daughter cherishes the heartfelt words exchanged through cards, highlighting the mother's pride, love, and unwavering support. The mother, who battled lung cancer, exemplified strength, devotion, and humor, leaving a lasting impact on her family. The daughter expresses gratitude for her upbringing and acknowledges the enduring connection with her mother, emphasizing that true love transcends physical separation.

A Tribute to Mom

TheAnswerToCancer.org website offers information to patients solely about cancer immunotherapy, a field of oncology that works to harness the body’s immune system to eradicate cancer cells. Developed by the Cancer Research Institute, a nonprofit organization that funds cancer immunology research, TheAnswerToCancer.org offers a glossary, news, patient profiles, resources, a clinical trials navigator service and information for patients. Individuals are encouraged to submit their own “immunostory” to share on the site. To learn more, visit 

TheAnswerToCancer.org is a dedicated platform providing comprehensive information on cancer immunotherapy, aiming to educate patients about leveraging the immune system to combat cancer. Created by the Cancer Research Institute, the site includes a glossary, news updates, patient stories, resources, and a clinical trials navigator. It encourages patients to contribute their personal experiences, termed "immunostories," to foster a community of shared knowledge and support. The platform serves as a valuable resource for patients seeking to understand and engage with immunotherapy options.

TheAnswerToCancer.org website offers information to patients solely about cancer immunotherapy.

TheAnswertoCancer.org

defenses against the fear and uncertainty that can accompany a cancer diagnosis is knowledge. Finding the right sources of information, however, can be tricky, even daunting. But it doesn’t have to be that way.

Beyond the patient’s health care team — the oncologist, nurses and other specialists who treat and provide support throughout the cancer journey &mdash; peers can be an important source of knowledge. Other patients who share their experiences with cancer and treatment provide a vital and often helpful perspective.

In addition, groups like the Cancer Research Institute (CRI), a nonprofit organization that since 1953 has worked to advance the field of cancer immunology, can help fill the gaps by providing resources that are reassuring, inspiring and even lifesaving.

CRI has created a number of resources for patients and caregivers seeking information about immunotherapy. These include a website providing updates on the latest in research and drug approvals for more than 20 major types of cancer, a webinar series featuring immunotherapy experts, an immunotherapy clinical trial finder service and a series of patient story videos.

These resources can help both patients who are eligible to take Food and Drug Administration (FDA)-approved immunotherapies and those whose cancers don’t respond to standard therapies and must look to experimental treatment. Such treatments usually are found in clinical trials that are testing new drugs, treatment combinations or ways to administer them. Some drugs may already be approved to treat some types of cancer but are undergoing testing in others.

Because these treatments are new or not yet approved, less may be known about their potential benefits and risks compared with conventional therapies. Patients may have

a lot of questions: “Will it work for me?” “How will I know it’s working?” “How will it make me feel?” “What are the known side effects?”

Recognizing the value of its resources in answering these questions for patients and caregivers, CRI decided in 2016 to provide an additional forum through which cancer-concerned communities can connect with one another and with scientific experts at the forefront

of cancer immunotherapy: the CRI Immunotherapy Patient Summit Series.

Over the past four years, the CRI summits, which are free to attendees, have brought the science of cancer immunotherapy to thousands of patients, caregivers and advocates, explaining in clear, accessible terms how scientists are unlocking the immune system’s natural ability to fight cancer.

Importantly, the summits also feature keynote presentations and panel discussions centered on patients who share their experiences in learning about and receiving immunotherapy, participating in clinical trials and overcoming cancer.

At a recent CRI Immunotherapy Patient Summit in Houston, attendees heard from keynote patient speaker K.C. Dill, who described how researching immuno- therapy and listening to other patients’ stories on the CRI website inspired, informed and empowered her to take action after chemotherapy and radiation failed to keep her cancer at bay.

When Dill learned in February 2015 that she had stage 3 non-small cell lung cancer, she was devastated and feared for the future of her husband and two daughters. Just 40 at the time, she never imagined that she’d face the same rare type of lung cancer, adenosquamous carcinoma, that her mother was battling. Sadly, a few years later, cancer would take her mother’s life.

“Leaving the hospital that day and going to my mother’s house to tell her I had the same kind of cancer she had was the hardest thing I’ve ever had to do,” Dill said in an interview with CRI 

Because her cancer was so advanced, Dill was ineligible for surgery. Instead, she began an aggressive regimen of radiation and chemotherapy that left her feeling sick, fatigued and in pain. After 15 weeks of severe side effects, Dill decided she’d had enough and needed another option. Meanwhile, the cancer had progressed to stage 4, spreading to her lymph nodes. Dill realized her odds of survival were rapidly dwindling. She sought a second opinion and different course of treatment at Baylor College of Medicine in nearby Houston. There, she heard the word “immunotherapy” for the first time.

Dill’s oncologist at Baylor, Dr. Jun Zhang, explained that although no immunotherapy had yet been approved by the FDA for her type of cancer, there were indications that Dill might respond to treatment with a type of immunotherapy called checkpoint blockade — specifically, the drug Opdivo (nivolumab), which interferes with cancer’s ability to disable the immune system’s attack.

The drug had received FDA approval earlier that year to treat another subtype of the disease called squamous non-small cell lung cancer and showed promise in other types of lung cancer.

After her initial consultation with Zhang, Dill returned home, went online to learn as much as she could about immunotherapy and found CRI’s website. She watched videos and read stories about others with advanced lung cancer who had been treated successfully with Opdivo. “I thought, ‘Wow, if it worked for them, it could work for me,’” Dill recalled.

She decided to find out if immunotherapy could help her immune system fight the cancer. Through the drugmaker’s compassionate use program, Dill began receiving treatments every two weeks. She describes the experience as unlike anything she endured while receiving chemotherapy and radiation. “After my first treatment, I felt a little sore and had some flu-like symptoms, but I was able to work out the next day,” she said.

After the first few weeks, Dill felt better than she had in a long time. “I had color back in my skin. My hair was growing back. I had more energy,” she said.

Just how well Dill was responding to immunotherapy quickly became apparent when the first scans showed that her tumors had all but disappeared. By spring 2016, she had no evidence of disease and stopped treatment later that year. She remains in remission, enjoying time with her family and spreading the word about cancer immunotherapy as a CRI ImmunoAdvocate.

“Immunotherapy has given me hope,” Dill said. “There are so many people out there this can help. Other patients that had come before me inspired me, so that’s my hope — to let my experience help the next person.”

In light of the COVID-19 pandemic and the unique risks and challenges it poses to patients with cancer, CRI has reimagined its in-person summit series as the CRI Virtual Immunotherapy Patient Summit.

The CRI Virtual Summit, which will take place in autumn 2020, promises to deliver the same high-quality, expert-curated information about cancer immunotherapy, along with inspiring, first-person accounts from patients. As with other CRI summits, this virtual event will include cancer-specific breakout sessions, allowing attendees to take a deeper dive into immunotherapy for the cancers that concern them most.

As cancer immunotherapy continues to become more widely available, CRI will continue to bridge the learning gap by providing trusted information for patients, caregivers and advocates. Meanwhile, CRI remains committed to funding promising research in immunology and immunotherapy so that, someday, all patients with cancer might be able to experience the potentially lifesaving benefits of this new treatment approach.

Knowledge is a powerful tool against the fear and uncertainty of a cancer diagnosis. Beyond healthcare teams, peer support and organizations like the Cancer Research Institute (CRI) offer valuable resources. CRI provides information on immunotherapy through websites, webinars, and patient stories. Their Immunotherapy Patient Summit Series connects patients with experts and peers, offering insights into immunotherapy's potential. The story of K.C. Dill illustrates the transformative impact of immunotherapy. In response to COVID-19, CRI transitioned to virtual summits, continuing to provide expert information and support for cancer patients.

Cutting-edge medical information and first-person accounts empower patients to evaluate immunotherapy as a treatment option, one organization attests.
 

H. Jack West, M.D.

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