Nichole Tucker

The oral small molecule FLX475 demonstrated promise when administered either alone or in combination with the immune checkpoint inhibitor pembrolizumab in multiple solid tumors, according to findings from a phase 1/2 dose-escalation and expansion study.

Plinabulin in combination with pegfilgrastim demonstrated a significant improvement in cycle 1 in the rate of prevention of grade 4 neutropenia due to chemotherapy treatment in patients with cancer in the phase 3 PROTECTIVE-2 trial.

In patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), findings from the ongoing phase 2 SPiReL study demonstrated that certain gene expressions are associated with response to DPX-Survivac plus pembrolizumab and intermittent, low-dose cyclophosphamide.

The FDA granted approval to pembrolizumab in combination with chemotherapy as treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.

In an interview with Targeted Oncology following the announcement of the FDA approval of azacitidine plus venetoclax in older patients with acute myeloid leukemia, Brian Jonas, MD, provided insight on the VILAE-A study results. He also gave expert advice on how to approach treating older patients with acute myeloid leukemia in every day practice.

The strategy of adding the plasmid IL-12 agent tavokinogene telseplasmid to pembrolizumab led to deep systemic responses in patients with actively progressing anti–PD-1–refractory advanced melanoma, according to interim results from the KEYNOTE-695 clinical trial.

Lenvatinib in combination with everolimus improved progression-free survival in patients with advanced renal cell carcinoma compared with sunitinib, meeting the primary end point of the phase 3 KEYNOTE-581/CLEAR clinical trial. Pembrolizumab added to lenvatinib, another experimental arm of the trial, also achieved a satisfactory overall response rate, meeting a key secondary end point.

The FDA has granted a Fast Track designation to CPI-613 for the treatment of metastatic pancreatic cancer.

As the field of lung cancers continues to lean further into the precision medicine era, KRAS G12C has become an emerging actionable target for which multiple therapies are under development, said Bob T. Li, MD.

During a debate, Nicholas J. Short, MD, argued that intensive chemotherapy combined with a BCR-ABL tyrosine kinase inhibitor still holds the place of standard-of-care treatment for Phildelphia chromosome acute lymphoblastic leukemia, while Sabina Chiaretti, MD, PhD, made the case for targeted therapy.

Treatment with neratinib achieved a high percentage of responses in patients with metastatic non–small cell lung cancer patients with EGFR exon 18 mutations who were dosed in a cohort during the interim analysis of the phase 2 SUMMIT basket trial.

A broad range of patients with heavily pretreated relapsed/refractory lower-risk myelodysplastic syndrome who were ineligible for treatment with an erythropoiesis-stimulating agent achieved durable red blood cell transfusion independence following treatment with the imetelstat, according to results from the phase 2 IMerge trial.

Here is a look back at the FDA happenings from the month of October 2020.

In genitourinary cancers, presentation of subgroup analysis data from large randomized clinical trials demonstrated findings that will change practice for oncologists who treat patients with prostate cancer, bladder cancer, and renal cell carcinoma.

The FDA has granted an Orphan Drug designation to CPI-613 for the treatment of soft tissue sarcoma.

The FDA has accepted the supplemental Biologics License Application for cemiplimab-rwlc and granted it Priority Review for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer with ≥50% PD-L1 expression.

In evaluating MYC rearrangement and its correlation with disease burden and prognostics in newly diagnosed multiple myeloma, a group of Mayo Clinic investigators found that the alteration is associated with high disease burden and independently prognosticates adverse outcomes in patients.

The FDA has granted approval to the FoundationOne Liquid CDx as a companion diagnostic indicated for the to identify patients who may derive benefit from treatment with 3 FDA-approved targeted therapies, including alpelisib, rucaparib, and alectinib.

The IDH1 inhibitor olutasidenib showed a favorable safety profile in patients with relapsed/refractory acute myeloid leukemia treated in a phase 1/2 clinical trial, according to topline results.

Historically, in gastrointestinal malignancies, chemotherapy and radiation were utilized to improve outcomes for patients. Although these treatments were effective, disease recurrence was always imminent, demonstrating a need for novel therapies.

The combination of ipatasertib and abiraterone acetate achieved a significantly superior radiographic progression-free survival and demonstrated anti-tumor activity compared with placebo and abiraterone in patients with metastatic castration resistant prostate cancer with PTEN loss, according to results from the phase 3 IPATential150 clinical trial.

Chimeric antigen receptor T-cell therapy with the novel agent CTX110 showed promising early efficacy and safety as treatment of patients with relapsed or refractory CD19-positive B-cell malignancies who were treated in the phase 1 CARBON clinical trial.

Driver alterations in neuregulin 1 fusions have recently come to light as a new target in patients with advanced or metastatic solid tumors. Multiple factors contribute to poor outcomes in this patients population with limited option for resolution.

Looking at the pipeline for larotrectinib, it shows an accelerated course, which can be attributed to the drug’s potential to fulfill an unmet need in oncology.

Two immune systems conditions, hypogammaglobulinemia and hypocomplementemia, may be predictive of adverse outcomes in patients with diffuse large B-cell lymphoma, according to a published study.

CART-PSMA-TGFβRd as adoptive chimeric antigen receptor T-cell therapy administered as treatment of patients with metastatic castration-resistant prostate cancer appears safe and feasible.

Afatinib, an FDA-approved frontline treatment for patients with metastatic non–small cell lung cancer, has now demonstrated efficacy and tolerable safety in the second-line setting of metastatic squamous cell carcinoma of the lung

Several late-phase results were shared during the European Society of Medical Oncology Virtual Congress in gynecologic malignancies, but the data presented generated excitement about the number of novel options for patients after initial treatment.

The FDA granted approval to venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine, a regimen known as LDAC, as treatment of adults patients with aged 75 years or older with newly-diagnosed acute myeloid leukemia or who have comorbidities precluding intensive induction chemotherapy.

During a Medical Crossfire at the 21st Annual International Lung Cancer Congress, Paul A. Bunn, Jr, MD, debated with Karen L. Reckamp, MD, MS, about frontline single-agent immune checkpoint inhibitors versus combined chemotherapy and immunotherapy for the treatment of patients with advanced NSCLC.