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Spotlight

This roundtable series discusses antibody-drug conjugates as therapy for patients with cervical cancer who had progressed on chemotherapy, as discussed by key opinion leaders and participants at virtual live events.

Treating Patients With Metastatic or Recurrent Cervical Cancer Post Chemotherapy

50-year-old Black woman busy with family, mother of college-aged children​

Now assisting parents, as her mother recovers from knee replacement surgery​

Gynecologist retired 2 years ago, and the patient has not identified a new obstetrician and gynecologist. ​

: Dyspareunia and post-coital vaginal bleeding​

Endocervical Biopsy: endocervical adenocarcinoma confirmed​

Pelvic MRI with contrast: involvement of lower vagina and pelvic sidewall​

Positive pelvic lymph node and hepatic metastasis​

Neck/Chest/Abdomen/Pelvis/Groin Fluorodeoxyglucose-PET/CT: liver metastasis​

Immunohistochemistry of Endocervical Biopsy Specimen: PD-L1 positive

Pembrolizumab (Keytruda) plus cisplatin/paclitaxel and bevacizumab (Avastin) was initiated at 6 cycles followed by an additional 6 cycles with pembrolizumab plus bevacizumab.

Patient complained of slight dyspnea and coughing​.

MRI: confirmed metastatic pulmonary nodules in right upper lobe.

: What were the baseline characteristics of the patients in the phase 2 InnovaTV 204/GOG-3023/ENGOT-cx6 trial (NCT03438396) given tisotumab vedotin-tftv (Tivdak)?

: There were low numbers of underrepresented minorities in this first study, unfortunately, where it was 95% White [patients], but it was otherwise reflective of the cervical cancer population as far as squamous cell carcinoma being the most common [diagnosis, followed by patients with] adenocarcinoma, and a few patients who had adenosquamous carcinoma.

 The majority of the patients had metastatic disease at baseline, so this was a measurable disease population. 

Fifty-four percent of patients had gotten cisplatin with their radiation, while 70% had 1 prior line of therapy and the rest had 2 prior lines of [therapy]. Sixty-three percent had bevacizumab with their chemotherapy doublet up front, and this is an important number that a lot of people don't notice because this is a population that did poorly with their upfront regimen. Fifty-six percent did not have any benefit from their frontline regimen, and that's impressively [not good]. 

This was before the KEYNOTE-826 [NCT03635567] study, so the majority of [these patients] did not get the 4-drug regimen, but this is a population that [didn’t respond well to initial treatment]. I think that's important to note, because sometimes I feel like in our trial populations you can tell [the patients] had benefit from their last regimen, [and in this case they didn't], so you always want to make sure you know what you have.

How did patients in this trial respond to treatment?

There was a 24% [confirmed] overall response rate and 7 patients had a complete response [CR].

 So this was exciting, [because it's] rare in the second-line cervical cancer population to see CRs to therapy. Seventeen percent had a partial response, and then a nice proportion of patients had a disease control rate of 72% [95% CI, 62.5%-80.7%]. This is important, because we always want to see a response to therapy...but for this population controlling [their] disease is important too. 

If they're doing well, they're tolerating your treatment, and you can stabilize their disease, that's [great], too.... The median duration of response was 8.3 months [95% CI, 4.2–not reached], but you could have patients [that are on this treatment] for years. The median progression free-survival [PFS] was 4.2 months [95% CI, 3.2-4.6], the 6-month PFS rate was 34% [95% CI, 24.3%-43.1%], and the overall survival was pushing 12 months after study enrollment.

These were the exciting data that led to the accelerated approval [of tisotumab vedotin by the FDA].

Were these results seen across all patient subgroups in the trial?

The majority of patients had some benefit [on this therapy].

 There was shrinkage of the disease...and the majority of these patients are staying in that positive area where they're at least getting disease stabilization or reduction. In the subgroups, [the investigators] looked at things like their histology, whether patients had cisplatin treatment, their response to their last regimen, and their ECOG performance status. 

Generally all [these subgroups favored tisotumab vedotin] from a response standpoint. They all showed a consistent response rate sitting around 20% to 30%. In fact, for some [of the observed subgroups] they still had a response to their last regimen, but a better chance of responding to this regimen. So, the positive prognostic factors were consistent in this patient population.

1. Coleman RL, Lorusso D, Gennigens C, et al; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. 

. 2021;22(5):609-619. doi:10.1016/S1470-2045(21)00056-5

2. FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. News release. September 21, 2021. Accessed: September 25, 2023. 

In the first article of a 2-part series, Shannon N. Westin, MD, MPH, looks at the promising responses to tisotumab vedotin for patients with recurrent or metastatic cervical cancer. 