
In an 8 to 5 vote, the FDA’s ODAC voted that data from two proposed single-arm trials will provide adequate means of characterizing the risk-benefit profile of dostarlimab for the treatment of patients with dMMR/MSI-H locally advanced rectal cancer.

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In an 8 to 5 vote, the FDA’s ODAC voted that data from two proposed single-arm trials will provide adequate means of characterizing the risk-benefit profile of dostarlimab for the treatment of patients with dMMR/MSI-H locally advanced rectal cancer.

The FDA has granted a regular approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

Emma L. Barber, MD, emphasized the importance of the ongoing phase 3 PORTEC-4a trial, which is investigating the role of molecular risk profiles in determining whether patients with endometrial cancer should receive no adjuvant therapy, vaginal brachytherapy, or external beam radiotherapy.

Investigators in the phase 2 SWOG S2107 trial are evaluating encorafenib plus cetuximab and nivolumab for patients with previously treated, microsatellite stable, unresectable, or metastatic colorectal cancer harboring a BRAF V600E mutation.

Elevation Oncology is pausing development of the human anti–HER3 IgG2 monoclonal antibody seribantumab, along with the phase 2 CRESTONE trial investigating the agent, in patients with advanced solid tumors harboring NRG1 fusions.

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Multiple teams working inside the Georgia Cancer Center at the Medical College of Georgia at Augusta University are committed to closing care gaps across Georgia.

The CAR T-cell therapy brexucabtagene autoleucel produced a median overall survival of 26 months in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Alfred L. Garfall, MD, discusses the durability of responses teclistamab elicited in the MajesTEC-1 trial and how this agent will change the treatment regimen for relapsed/refractory multiple myeloma.

Roy S. Herbst, MD, PhD, discussed the data that supported the FDA approval of adjuvant pembrolizumab in patients with non–small cell lung cancer, highlighted the implications of the approval for the paradigm, and outlined further research opportunities.

Oral progesterone receptor antagonist onapristone extended release in combination with anastrozole induced a confirmed partial response in 2 patients with hormone receptor–positive metastatic endometrial cancer.

Bartosz Chmielowski, MD, discusses the rationale for IGNYTE, the unique mechanism of action of RP1, and how melanoma research is seeking to determine treatments for patients based on their individual resistance mechanisms.

The FDA has granted an orphan drug designation to ezurpimtrostat, a PPT-1 inhibitor for the treatment of patients with hepatocellular carcinoma.

Caspian Oliai, MD, discusses how treatment with Orca-T demonstrated a reduction in graft-vs-host disease and non-relapse mortality rates, while also producing higher than expected graft-vs-leukemia and graft-vs-infection effects, in patients with hematologic cancers at more than 1 year of follow-up.

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Age-based heuristics can lead to large differences in breast cancer treatment based on small differences in chronologic age, according to a new analysis of more than 500,000 patient records.

For decades, resection of the primary tumor, either up front or after neoadjuvant therapy, has remained the standard of care for patients with early-stage (stage I-III) colorectal cancer. Recently, a plethora of data have been published that might change the current surgery-centered paradigm.

Despite the favorable comments and interest in clinical trials, the objective fact is that a distressingly low percentage of patients with cancer, in the range of 2% to 4%, are enrolled in clinical investigative efforts.

The selective small molecule MDM2 inhibitor milademetan administered at an intermittent dosing schedule was tolerable and showed early efficacy in patients with advanced cancers, according to findings from a phase 1 study.

Lamanna discussed key efficacy and safety data with zanubrutinib from the SEQUOIA and ALPINE trials, the advantages of zanubrutinib compared with previous therapeutic options, and how the approval of the agent will affect the use of next-generation BTK inhibitors in chronic lymphocytic leukemia and small lymphocytic lymphoma .

To continue making progress in lung cancer treatment, investigators must keep pushing the science in new directions even as immunotherapy becomes more available in earlier lines.

With 2 KRAS G12C inhibitors showing encouraging results in combination with anti-EGFR agents, there is a ray of hope for patients with recurrent colon cancer–a treatment that may offer patients the chance to make it to important milestones.

Avero Diagnostics has launched AMBLor, a first-of-its-kind laboratory test for the identification of early-stage melanoma at low risk of progression.

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Cardiovascular diseases are the follow-up threats many men face after undergoing androgen deprivation therapy, also known as hormonal treatment, for prostate cancer.

Treatment with crovalimab led to disease control through transfusion avoidance and control of hemolysis in patients with paroxysmal nocturnal hemoglobinuria who have not been previously treated with complement inhibitors.

An economic analysis showed that neither polatuzumab vedotin-piiq added to standard of care chemotherapy nor CD19-directed chimeric antigen receptor T-cell therapy is likely to be the most cost-effective for patients with diffuse large B-cell lymphoma.

The safety and efficacy of a combination regimen comprised of XL092 and atezolizumab is being compared with that of regorafenib monotherapy in patients with microsatellite stable or microsatellite instability–low metastatic colorectal cancer who have progressed on or are intolerant to standard-of-care therapy.

If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.

As more agents are evaluated either in addition to or following PD-1/PD-L1 inhibitors, more information may be learned about how best to leverage alternate biomarkers, according to Marina C. Garassino, MD.

FDA approvals in recent years have started to carve out a role for immunotherapy in the frontline treatment of patients with small cell lung cancer.

The RaDaR assay successfully identified the patients with locoregionally advanced urothelial cancer most likely to benefit from treatment with ipilimumab and nivolumab in findings from the second cohort of the phase 1b/2a NABUCCO trial.

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Fox Chase Cancer Center physicians Hossein Borghaei, DO, MS, and Elizabeth Plimack, MD, MS, have been named to the 2022 list of Highly Cited Researchers by Clarivate.