Cancer Vaccine Breaking News

Cancer vaccine breaking news brought to you by Vax Before Cancer.

May 8, 2021 • 12:59 pm CDT

A global biotechnology company announced that its PARP inhibitor pamiparib had received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

BeiGene, Ltd.'s new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) in July 2020. 

Beijing and Cambridge, MA-based BeiGene stated in its press release issued on May 7, 2021, it is preparing to launch pamiparib this month (May'21).

“Today’s NMPA approval makes pamiparib the third BeiGene internally discovered and developed medicine to receive marketing authorization, an incredible company milestone validating our scientific innovations,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene, in a press statement.

The NMPA conditional approval of pamiparib for treating patients with advanced ovarian, fallopian tube, or primary peritoneal cancer is based on clinical results from a pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915). A total of 113 patients in China with high-grade, non-mucinous, epithelial ovarian cancer (including fallopian or primary peritoneal cancer), harboring gBRCA mutations, following at least two prior lines of standard chemotherapy, were enrolled in the pivotal Phase 2 portion of the trial, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC), and 23 patients with advanced platinum-resistant ovarian cancer (PROC).

Clinical efficacy data in the pamiparib label in China, as assessed by the independent review committee (IRC) per RECIST v1.1, were based on 101 patients evaluable for efficacy analysis, including 82 patients with PSOC and 19 patients with PROC.

For patients with PSOC, with a median follow-up time of 17.0 months, the objective response rate (ORR) was 68.3% (95% CI: 57.1, 78.1), and the median duration of response (DoR) was 13.8 months (95% CI: 10.97, 20.73); for patients with PROC, the median follow-up time was 11.6 months, the ORR was 31.6% (95% CI: 12.6, 56.6) and the median DoR was 11.1 months (95% CI: 4.21, 16.59).

The safety profile of pamiparib in the label in China was based on 317 patients who received pamiparib as monotherapy in three clinical trials. The most common adverse reactions (≥10%) were anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, decreased appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, blood bilirubin increased, and lymphopenia.

Grade ≥3 adverse reactions occurred in 55.8% of patients, with the most common (≥1%) being anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, nausea, and AST increased. Serious adverse reactions occurred in 21.5% of patients, with the most common (≥1%) anemia and leukopenia.

The recommended dose of pamiparib is 60 mg twice daily (BID) taken orally.

In China, ovarian cancer is the deadliest gynecologic cancer, responsible for approximately 22,500 deaths every year, and the five-year survival rate among Chinese patients is about 40%.

Pamiparib is an inhibitor of PARP1 and PARP2, which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.

To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

In China, pamiparib received conditional approval to treat patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit

Medical Review by
May 7, 2021 • 4:57 am CDT

Bellevue-based Viome announced its proprietary mRNA analysis technology combined with its next-generation AI platform had been designated a Breakthrough Device by the Food and Drug Administration (FDA) for early detection of oral cancer and throat cancer.

Making saliva the new liquid biopsy, Viome analyzes samples for the presence of Oral Squamous Cell Carcinoma and Oropharyngeal Cancer.

Viome has employed unique mRNA analysis technology and breakthrough machine learning techniques to accurately discover the interactions between microbial activities and human gene expression in the progression of these cancers.

Founded in Washington during 2016, Viome has become a global healthcare company, developing precision nutrition, precision drugs, and precision vaccines to help people live a disease-free life.

May 6, 2021 • 1:41 pm CDT

Basel-based Roche announced on May 5, 2021, that the European Commission has approved Tecentriq® (atezolizumab) as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” commented Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, in a press statement.

“Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”

Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three, or four weeks, giving physicians and patients greater flexibility on how they manage their treatment.

Roche has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.

This includes studies evaluating Tecentriq both alone and in combination with other medicines and studies in metastatic, adjuvant, and neoadjuvant settings across various tumor types.

Founded in 1896, Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics and a frontrunner in diabetes management. 

Medical Review by
May 5, 2021 • 10:57 am CDT

A clinical-stage immunotherapy company based in The Netherlands dedicated to developing immunotherapeutics for oncology and infectious diseases announced the publication in Nature Reviews Cancer on May 4, 2021, a review of therapeutic cancer vaccines.

The Nature Reviews Cancer paper summarizes key insights gleaned from previous successful and non-successful therapeutic vaccine trials. It provides an overview of the numerous mechanisms cancer cells use to evade treatment and strategies that can significantly enhance the clinical efficacy of immunotherapies.

The paper is co-authored by ISA's Chief Scientific Officer, Prof. Cornelis "Kees" Melief, in collaboration with key opinion leaders at international institutions, including the Icahn School of Medicine at Mount Sinai, New York.

Prof. Kees Melief, ISA Pharmaceuticals, said in a press release, "Therapeutic cancer vaccines have undergone a resurgence in the past years. This paper highlights key cancer vaccine trials with clinical impact and provides insight on how to improve crucial T cell immune responses and co-treatment for clinical success."

"Our Synthetic Long Peptide (SLP®) technology is amongst the most successful platforms."

"We have safely completed multiple human clinical studies in hundreds of patients, showing a consistently positive correlation between the size of the vaccine-induced immune response and the clinical response."

ISA Pharma is an immunotherapy company developing treatments for various cancers and infectious diseases.

May 3, 2021 • 8:16 pm CDT

Vancouver-based BioVaxys Technology Corp. announced today that it had signed the definitive exclusive bioproduction agreement with BioElpida S.A.S. of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys' vaccine candidate for Stage III/Stage IV ovarian cancer.  

BioVaxys expects to prepare its regulatory submission for a Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of 2021, with vaccine supply for the planned clinical study available in May 2022.

Kenneth Kovan, Co-Founder, President, and Chief Operating Officer of BioVaxys, commented in a press release, "BioElpida's technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those who have advanced ovarian cancer."

BioVaxys is also collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a clinical trial application BVX-0918A to the European Medicines Agency later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer.

Worldwide, over 300,000 women are diagnosed with ovarian cancer each year, the leading cause of death from gynecologic malignancy in the USA.

BioVaxys Technology Corp. is a British Columbia-registered, an early-stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. 

May 1, 2021 • 2:45 pm CDT

Osaka-based Takeda Pharmaceutical Company Limited announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

“Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, Head of Oncology Therapeutic Area Unit Takeda, in a press release issued on April 27, 2021.

“We are excited to be one step closer to offering mobocertinib as an effective oral therapy for NSCLC patients with EGFR Exon20 insertions that have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the U.S. and around the globe.”

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which evaluates the safety and efficacy of oral mobocertinib in patients with mNSCLC.

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R & R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet.

Apr 30, 2021 • 3:13 pm CDT

Recent research from Washington University School of Medicine in St. Louis has shown that an innovative approach can be used to create personalized vaccines that program the immune system to attack malignant tumors, including breast and pancreatic cancers.

The tailor-made vaccines are designed to target mutated proteins called neoantigens unique to a patient’s tumors.

Unlike mRNA vaccines, these personalized cancer vaccines are made using DNA.

“We took a small tissue sample from a tumor in a 25-year-old male patient with late-stage pancreatic cancer and used it to develop a personalized vaccine based on the unique genetic information in that tumor,” said William Gillanders, M.D., senior author and professor of surgery at the School of Medicine, in a press release.

“We think this is the first report of the use of a neoantigen DNA vaccine in a human, and our monitoring confirms the vaccine was successful in prompting an immune response that targeted specific neoantigens in the patient’s tumor.”

Published April 21, 2021, in the journal Genome Medicine, this study explores how techniques used to create personalized cancer vaccines can be improved to help the body unleash a more effective, longer-lasting, tumor-fighting immune response.

The findings also show that a personalized DNA vaccine coupled with other immunotherapies can generate a robust immune response capable of shrinking breast cancers in mice. While the DNA vaccine did not shrink tumors in the pancreatic cancer patient, it did produce a measurable immune response that targeted the tumor.

Gillanders, who treats breast cancer patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, said DNA vaccine platforms offer some important advantages over other personalized vaccine platforms now in early clinical trials relying on mRNA, dendritic cells, and synthetic peptides.

Because the neoantigen DNA vaccine focuses the immune response on neoantigens that exist only in tumor cells, it lowers the risk of dangerous side effects, such as damage to normal healthy tissues or the triggering of intolerance or bad reaction to the vaccine.

“DNA vaccines are relatively easy and cost-effective to manufacture compared with other neoantigen vaccine platforms such as those that use dendritic cells or mRNA, for example, making the DNA vaccine platform attractive for neoantigen vaccines,” Gillanders added.

“The DNA vaccine platform also can be readily engineered to include multiple neoantigens. Additional immune modulators can also be integrated into the vaccine to increase the immune responses.”

Like other personalized vaccines now under development, the DNA vaccine platform targets neoantigens, abnormal protein fragments that are created as cancerous tumor cells mutate and grow. Since each cancer generates unique mutations, each DNA vaccine is also unique and optimized to target multiple neoantigens simultaneously.

Each neoantigen in the vaccine raises a red flag for the immune system, sending an army of specialized immune cells called T cells to seek and destroy the tumor.

While the process seems simple in theory, the devil is in the details, and those details reside within the complex inner workings of how cells process and present the neoantigens to the immune system.

For the vaccine to be successful, the neoantigens must be presented to cells in a precise format that maximizes the odds of triggering a complex, step-by-step cascade of natural immune responses. Any misstep may result in a weakened or even failed immune response.

As the new study documents, the neoantigen DNA vaccine can be optimized to improve the presentation process. Small differences in the length of an epitope (the part of the antigen recognized by the immune system), spacing, and amino acid sequence can result in important changes in how neoantigens are presented to the immune system. Even then, cancers often find ways to evade successful attacks.

The findings suggest that longer epitope fragments are more effective at triggering a longer-lasting immune response that includes both CD8 and CD4 T cells; that a mutant marker that tags neoantigens and is cloned to the end of an epitope string can significantly increase its recognition by the immune system; and that even the most well-presented epitopes are seldom successful at shrinking tumors unless accompanied by an additional immunotherapy tool, such as anti-PD-L1 checkpoint blockade.

“Although the initial clinical experience is promising, there is more work to do to refine the vaccines and evaluate their effectiveness in animal models and clinical trials. But this is an important first step and points us in the right direction,” Gillanders said.

Susan G. Komen supported this work for the Cure, grant number KG111025; the Alvin J. Siteman Cancer Center, Investment Program grant 4035; the National Institute of Health (NIH), R01CA240983; the National Cancer Institute, Cancer Center Support Grant P30-CA091842, and SPORE in Pancreatic Cancer, P50-CA196510; NCI training grant T32 CA 009621; and The Foundation for Barnes-Jewish Hospital.

Washington University School of Medicine’s 1,500 faculty physicians also is the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. 

Medical Review by
Apr 30, 2021 • 2:34 pm CDT

A recent study evaluated the question 'how often is cervical cancer screening tests overused in women with average risk in the United States?

While cervical cancer screening with cytologic and human papillomavirus (HPV) testing has reduced mortality from cervical cancer, overuse of these tests is associated with downstream psychological and medical consequences, as well as high costs.

In this cohort study of 2,299,177 commercially insured women aged 30 to 65 who underwent cervical cancer screening in 2013 through 2014, about 64% underwent repeat testing within 36 months of index testing.

After the index screening test, women who did not undergo repeat screening were significantly less likely to undergo a gynecological exam.

In summary, these researchers said, 'These findings suggest that despite evidence-based guidelines, overuse of cervical cancer screening tests was common.'

The 2012 American Cancer Society guidelines for cervical cancer screening recommend using cytologic screening every 3 years or co-testing with HPV and cytologic testing every 5 years in women aged 30 to 65 years. More recently, guidelines have been updated to advocate for primary HPV testing every 5 years as the preferred approach to screening in all women aged 25 to 65.

Medical Review by
Apr 13, 2021 • 2:21 pm CDT

China-based LintonPharm Co., Ltd. announced that the National Medical Products Administration had authorized the company to proceed with a Phase 1/2 clinical trial evaluating the safety and efficacy of catumaxomab in patients with Non-Muscle-Invasive Bladder Cancer whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure.

This is LintonPharm’s second clinical program evaluating catumaxomab. In July 2020, the company announced the authorization of a Phase 3 trial in advanced gastric cancer which screened its first patient in October 2020.

Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany (NCT04819399) and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.

“Regulatory clearance to move forward with our clinical program evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers,” commented Robert Li, Ph.D., DABT, Co-founder and CEO of LintonPharm, in a press release. 

“Patients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients.”

Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period.

NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer.

Transurethral resection of bladder tumor (TURBT) is the current standard of treatment for NMIBC. Relapse is common after TURBT (up to 70 percent at five years) and as a result, patients often undergo multiple surgical procedures over a longer period. 

Intravesical BCG is commonly used as an adjuvant treatment after TURBT. However, a large number of patients experience tumor recurrence, which is referred to as BCG failure. Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites.

This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell--the epithelial cell adhesion molecule (EpCAM)--and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer.

LintonPharm Co., Ltd. is a clinical-stage, research-oriented biopharmaceutical company committed to developing innovative T cell engaging bispecific antibodies with the goal of turning malignant cancers into manageable and possibly curable diseases.

Apr 12, 2021 • 2:22 pm CDT

Austria-based HOOKIPA Pharma Inc. announced on April 10, 2021, positive preliminary Phase 1 immunogenicity data for its immunotherapy candidates to treat advanced HPV16+ cancers.

The data demonstrated a robust increase in HPV16+-specific T cells, including up to 8% of circulating CD8+ T cells, after one dose of HB-201 or HB-202. And early data on HB-201 monotherapy show an increase in interferon-gamma and other immune stimulatory cytokines after a single dose, highlighting immune system activation.

Furthermore, late-breaking data presented at the AACR Annual Meeting reinforced promising anti-tumor activity reported in 2020 and underscore the potential of HOOKIPA’s novel arenavirus platform to deliver transformational cancer therapies.

“Treatment options are limited for people with metastatic HPV16+ cancers, and the likelihood for long-term survival is low,” stated Dmitriy Zamarin, M.D., Ph.D., Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study, in a press release.

“We don’t often see this robust and high-quality immune response, particularly in antigen-specific CD8+ T cells, from a single dose and without any combination therapy. I’m excited to see how these early immunogenicity data may translate to clinical outcomes in the future.”

The company stated 'these preliminary immunogenicity data reinforce the promising anti-tumor activity reported from this trial in December 2020 and are consistent with recently published preclinical data, which showed that intravenous HB-201 administration induced single-digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeding 50% of the circulating T cell pool.'

As the HB-201/HB-202 clinical trial is ongoing, HOOKIPA indicated it expects to present additional translational and clinical data at upcoming medical conferences in 2021.

HOOKIPA Pharma Inc. (HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform reprograms the body’s immune system.

Apr 8, 2021 • 2:56 pm CDT

California-based Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).

Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse.

“A metastatic TNBC diagnosis is frightening. As an aggressive and difficult-to-treat disease, it’s a significant advance to have an FDA-approved treatment option with a proven survival benefit for patients with metastatic disease that continues to progress,” commented Ricki Fairley, Founder, and CEO of Touch, the Black Breast Cancer Alliance, in a press statement.

“For far too long, people with metastatic TNBC had very few treatment options. Today’s news continues the progress of bringing more options to treat this devastating disease.”

TNBC is an aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is more prevalent in African American and Hispanic women

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Mar 31, 2021 • 10:44 am CDT

North Carolina-based Istari Oncology, Inc. announced that the first patient was dosed in the LUMINOS-102 phase 2 clinical trial, which will assess the safety and efficacy of PVSRIPO alone or in combination with a programmed death receptor-1/ligand 1 (PD-1/L1) inhibitor in patients with melanoma who are resistant to these checkpoint therapies.

PVSRIPO is a novel viral immunotherapy that activates the innate and adaptive immune system to stimulate the production of a functional, systemic anticancer CD8+ T cell response.

“Anti-PD-1/L1 therapies have been a major advancement in melanoma treatment, however, many patients develop resistance or never respond in the first place,” said Matt Stober, President, and CEO at Istari Oncology, in a related press statement.

“We are very optimistic about the prospects for the phase 2 trial. PVSRIPO monotherapy has already shown clinical activity in this population, and its mechanism is synergistic with anti-PD-1/L1 therapies, so we believe the combination may provide even more benefit.”

Following positive phase 1 results, the phase 2 trial will further explore PVSRIPO’s impact on this population of patients in severe need of additional therapeutic options.

Medical Review by
Mar 28, 2021 • 10:01 am CDT

A new study published in the journal Nature on March 25, 2021, reveals promising results of phase 1 clinical trial testing of a novel brain cancer vaccine that's designed to assist a patient's immune system respond to certain brain tumors.

Diffuse gliomas are a type of brain cancer that is difficult to treat and can spread well across the brain, making it extremely difficult to eliminate through conventional surgery.

The published data suggest that the IDH1 peptide vaccine stimulated a critical immune response that slows tumor progression.

The NOA-16 study included 36 patients and met its primary endpoints by demonstrating the safety and immunogenicity of IDH1-vaccine in patients with newly diagnosed WHO grade 3 and 4 IDH1(R132H)+ astrocytomas without further positive prognostic factors.

Immunogenicity, irrespective of HLA type, and the high rate of PsPD warrant further clinical investigation of IDH1-vac. Patients who did not mount an IDH1-vac induced immune response showed reduced efficacy of the vaccine and disease progression within two years.

Targeting a shared clonal driver mutation in newly diagnosed patients overcomes these limitations6. It may provide a basis for future trials that target MHCII-restricted clonal shared and personalized neoepitopes in cancer immunotherapy.

Currently, a larger Phase 2 clinical trial is being planned, said these researchers.

Medical Review by
Mar 28, 2021 • 9:45 am CDT

The U.S. Food and Drug Administration (FDA) announced the approval of Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.

Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.

“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement issued on March 27, 2021.

“While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer.” 

Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, resulting in low blood counts, says the FDA.

Medical Review by
Mar 25, 2021 • 6:29 am CDT

New York-based Pfizer Inc. announced today real-world evidence (RWE) demonstrating that first-line therapy with IBRANCE® (palbociclib) in combination with letrozole was associated with improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (mBC) compared with letrozole alone.

This analysis showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole. The rwPFS and OS benefits were generally consistent across all subgroups, including younger patients (18-50 years of age) and site or extent of metastases.

IBRANCE is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression.

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research.

Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development, stated in a press release, “With more than six years of patient experience, a positive benefit-risk profile, strong clinical data, and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”

Since the U.S. Food and Drug Administration's initial approval more than six years ago, IBRANCE has been prescribed to more than 380,000 patients across more than 100 countries.

Pfizer Oncology is committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood, and lung cancers, as well as melanoma.

Medical Review by