Αρχική World News New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma

New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma

August 2, 2018, by NCI Staff

Metastatic cervical cancer cells.

Credit: National Cancer Institute

In June, the Food and Drug Administration (FDA) further expanded the approved uses of the immunotherapy drug pembrolizumab (Keytruda). The two recent approvals cover the use of pembrolizumab for some women with advanced cervical cancer and for adults and children with relapsed or treatment-resistant primary mediastinal large B-cell lymphoma (PMBCL), a rare type of aggressive non-Hodgkin lymphoma.

Both actions by FDA were accelerated approvals, meaning further studies are needed to confirm the drug’s clinical benefit in patients with these cancers.

Pembrolizumab is a type of immunotherapy called an immune checkpoint inhibitor. It works by blocking the binding of PD-1, a protein expressed on cytotoxic T cells, to the PD-L1 protein expressed on some cancer cells, an interaction that acts as a brake on the immune system and prevents T cells from attacking the cancer.

First Approval of a PD-1 Inhibitor for Cervical Cancer

On June 12, FDA approved pembrolizumab to treat women with cervical cancer that has recurred or spread (metastasized) to other parts of the body and gotten worse during or after chemotherapy. The approval makes pembrolizumab the first immune checkpoint inhibitor approved to treat cervical cancer.

Under the approval, patients’ tumors must express PD-L1, as determined by an FDA-approved laboratory test. FDA simultaneously approved the PD-L1 IHC 22C3 pharmDx test (manufactured by Dako North America, Inc.), as a companion diagnostic test for women with cervical cancer.

The accelerated approval was based on results from a single cohort of 98 women with cervical cancer who were enrolled in an ongoing phase 2 clinical trial of pembrolizumab for the treatment of several cancer types. The trial, called Keynote-158, is sponsored by Merck, the drug’s manufacturer.

Of the 98 women, 77 had tumors that expressed PD-L1. Two of these women had their tumors disappear completely (complete responses) and nine had their tumors shrink by 30% or more (partial responses), for an overall response rate of 14.3%. In 10 of the 11 women who responded to pembrolizumab, the responses lasted 6 months or longer, and after nearly 12 months of follow-up, the median duration of response had not been reached. None of the women with PD-L1–negative tumors responded to pembrolizumab.

Nearly 40% of the women experienced serious side effects, including anemia (7%), fistula (4%), infection (4%), or hemorrhage (4%), and 8% of the patients had to stop treatment because of them. The most common side effects included fatigue, pain, nausea and vomiting, and difficulty breathing (dyspnea).

The current standard of care for women with cervical cancer that has recurred or metastasized after previous treatment is chemotherapy in combination with bevacizumab (Avastin). FDA approved the combination regimen in 2014 based on results of an sponsored randomized phase 3 trial showing a 3.7-month improvement in median overall survival with the addition of bevacizumab to chemotherapy.

The clinical trials that led to the approvals of bevacizumab and pembrolizumab for cervical cancer that recurs or spreads and worsens during or after chemotherapy had different designs and goals, so “it’s not possible to compare the two regimens given the data currently available,” said Elise Kohn, M.D., Gynecologic Cancer Therapeutics Lead in NCI’s Cancer Therapy Evaluation Program.

“We now have two very different approved therapeutic options for these patients,” she said, “so patients should discuss the pros and cons of each regimen with their physicians before deciding on their treatment.”

Dr. Kohn stressed that patients and clinicians need to weigh the risks of side effects when considering the treatment options.

“Although the patterns of toxicity are different, they are not insignificant for either option,” she explained.

New Treatment Option for Rare Lymphoma

On June 13, FDA approved pembrolizumab for the treatment of adult and pediatric patients with PMBCL that is resistant to available treatments (refractory) or returned following treatment with two prior therapies.

The accelerated approval was based on results from a multicenter single-arm phase 2 trial called Keynote-170. The trial, sponsored by Merck, included 53 patients between the ages of 20 and 61 with relapsed or refractory PMBCL.

Although there were no children in the trial, “efficacy for pediatric patients with PMBCL was extrapolated from the results in the adult PMBCL population,” according to a Merck news release, and safety was determined based on “a study of 40 pediatric patients with advanced melanoma, lymphoma, or PD-L1–positive advanced, relapsed, or refractory solid tumors” who were treated with pembrolizumab.

The overall response rate  in the Keynote-170 trial was 45%, with 11% of patients achieving a complete response and 34% experiencing a partial response. At an average follow-up of nearly 10 months, the median duration of response had not yet been reached.

In its approval notice, FDA stated that pembrolizumab should not be used in patients who have an urgent need for surgery to reduce a PMBCL mass that may be compressing a major blood vessel or other critical structure within the mediastinum.

The most common side effects of pembrolizumab in the Keynote-170 trial included musculoskeletal pain, upper respiratory tract infection, fever, fatigue, and dyspnea. Serious side effects occurred in 26% of patients, causing 15% to interrupt therapy and 8% to discontinue treatment with pembrolizumab entirely. Twenty-five percent of patients had side effects that required treatment with corticosteroids.

“In the short follow-up thus far, there haven’t been signs of increased toxicity compared to other trials of PD-1 inhibitors,” said Mark Roschewski, M.D., of the Lymphoid Malignancies Branch in NCI’s Center for Cancer Research. “But PMBCL patients are often young and female, so longer follow-up will be important for these patients because their lifetime risk of developing autoimmune diseases is much higher” than older patients treated with PD-1 inhibitors, he emphasized. 

The distinction between patients with refractory PMBCL after first-line therapy and those who have relapsed or still have refractory disease following two previous lines of therapy is important, said Dr. Roschewski. Patients who have not been cured despite two previous lines of therapy—the patients covered by this approval—have a very poor prognosis. 

“These patients need better therapies,” he said. “Now that we have an approved drug in PMBCL, it opens the possibility of combination therapy studies, such as pembrolizumab and CAR T-cell therapy, for example.”



Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...


Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...


ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

Foodie Friday: It’s Berry Season!

July is National Berry Month! If berries aren’t part of your daily diet, now is the perfect time to start eating more of these...

No Link Between Viral Vector in Zynteglo and Acute Myeloid Leukaemia

On 23 July 2021, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) has endorsed findings of...

Expecting Mom Finds Pregnant Stray Cat And Gives Her A Home

A woman was 9 months pregnant when she found a pregnant stray cat. Unable to bear the thought of the fellow mom giving birth...

3 Questions Cancer Caregivers Can Ask Themselves to Help Prevent Burnout

Karen Warner Schueler is the president of her own executive coaching firm and author of The Sudden Caregiver: A Roadmap for Resilient Caregiving. For...

FDA Approval of Rylaze Will Address Drug Shortage for Childhood ALL

July 29, 2021, by NCI Staff FDA's approval of Rylaze is expected to help address a long-running shortage of the drug Erwinia asparaginase for kids...

EMA Recommends Granting a Marketing Authorisation for the Hybrid Medicine Imatinib

On 22 July 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting...